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PHARMACEUTICAL MANUFACTURING HANDBO
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PHARMACEUTICAL MANUFACTURING HANDBO
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CONTRIBUTORS Susanna Abrahms é n -
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CONTRIBUTORS vii Eddy Castellanos G
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CONTENTS PREFACE xiii SECTION 1 MAN
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CONTENTS xi 5.11 Transdermal Drug D
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SECTION 1 MANUFACTURING SPECIALTIES
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4 BIOTECHNOLOGY-DERIVED DRUG PRODUC
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6 BIOTECHNOLOGY-DERIVED DRUG PRODUC
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8 BIOTECHNOLOGY-DERIVED DRUG PRODUC
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10 BIOTECHNOLOGY-DERIVED DRUG PRODU
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12 BIOTECHNOLOGY-DERIVED DRUG PRODU
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14 BIOTECHNOLOGY-DERIVED DRUG PRODU
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16 BIOTECHNOLOGY-DERIVED DRUG PRODU
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18 BIOTECHNOLOGY-DERIVED DRUG PRODU
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20 BIOTECHNOLOGY-DERIVED DRUG PRODU
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22 BIOTECHNOLOGY-DERIVED DRUG PRODU
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24 BIOTECHNOLOGY-DERIVED DRUG PRODU
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26 BIOTECHNOLOGY-DERIVED DRUG PRODU
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28 BIOTECHNOLOGY-DERIVED DRUG PRODU
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30 BIOTECHNOLOGY-DERIVED DRUG PRODU
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32 BIOTECHNOLOGY-DERIVED DRUG PRODU
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34 REGULATORY CONSIDERATIONS IN APP
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36 REGULATORY CONSIDERATIONS IN APP
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38 REGULATORY CONSIDERATIONS IN APP
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40 REGULATORY CONSIDERATIONS IN APP
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42 REGULATORY CONSIDERATIONS IN APP
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44 REGULATORY CONSIDERATIONS IN APP
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46 REGULATORY CONSIDERATIONS IN APP
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48 REGULATORY CONSIDERATIONS IN APP
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50 REGULATORY CONSIDERATIONS IN APP
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52 REGULATORY CONSIDERATIONS IN APP
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54 REGULATORY CONSIDERATIONS IN APP
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56 REGULATORY CONSIDERATIONS IN APP
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1.3 RADIOPHARMACEUTICAL MANUFACTURI
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The terms tracer, radiotracer , and
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number of atoms that disintegrate d
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images that can also give quantitat
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PRODUCT DEVELOPMENT 67 Product Stab
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MANUFACTURING ASPECTS 69 stations s
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In general, the manufacturing of mo
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MANUFACTURING ASPECTS 73 Production
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PRODUCT MANUFACTURING 75 tainer. Th
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PRODUCT MANUFACTURING 77 practical
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PRODUCT MANUFACTURING 79 these radi
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PRODUCT MANUFACTURING 81 Most of th
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PRODUCT MANUFACTURING 83 PET Radiop
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PRODUCT MANUFACTURING 85 FIGURE 5 S
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PRODUCT MANUFACTURING 87 tions in t
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QUALITY CONSIDERATIONS 89 regulatio
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L1 L2 TC-MDP + Hydr. Tc TC-MDP + Tc
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EXTEMPORANEOUS PREPARATION OF RADIO
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Independent of which regulation app
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SECTION 2 ASEPTIC PROCESSING
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100 STERILE PRODUCT MANUFACTURING 2
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102 STERILE PRODUCT MANUFACTURING A
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104 STERILE PRODUCT MANUFACTURING T
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106 STERILE PRODUCT MANUFACTURING E
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108 STERILE PRODUCT MANUFACTURING I
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110 STERILE PRODUCT MANUFACTURING 2
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112 STERILE PRODUCT MANUFACTURING c
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114 STERILE PRODUCT MANUFACTURING 2
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116 STERILE PRODUCT MANUFACTURING 2
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118 STERILE PRODUCT MANUFACTURING i
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120 STERILE PRODUCT MANUFACTURING o
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122 STERILE PRODUCT MANUFACTURING a
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124 STERILE PRODUCT MANUFACTURING a
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126 STERILE PRODUCT MANUFACTURING e
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128 STERILE PRODUCT MANUFACTURING A
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130 STERILE PRODUCT MANUFACTURING 2
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132 STERILE PRODUCT MANUFACTURING p
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134 STERILE PRODUCT MANUFACTURING 2
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SECTION 3 FACILITY
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140 EFFECT OF SCALE-UP ON OPERATION
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142 EFFECT OF SCALE-UP ON OPERATION
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144 EFFECT OF SCALE-UP ON OPERATION
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146 EFFECT OF SCALE-UP ON OPERATION
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148 EFFECT OF SCALE-UP ON OPERATION
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150 EFFECT OF SCALE-UP ON OPERATION
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152 EFFECT OF SCALE-UP ON OPERATION
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154 EFFECT OF SCALE-UP ON OPERATION
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156 EFFECT OF SCALE-UP ON OPERATION
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158 EFFECT OF SCALE-UP ON OPERATION
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160 PACKAGING AND LABELING 3.2.1 3.
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162 PACKAGING AND LABELING signifi
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164 PACKAGING AND LABELING Although
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166 PACKAGING AND LABELING componen
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168 PACKAGING AND LABELING sions. T
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170 PACKAGING AND LABELING TABLE 1
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172 PACKAGING AND LABELING the stab
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174 PACKAGING AND LABELING and accu
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176 PACKAGING AND LABELING The safe
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178 PACKAGING AND LABELING If the p
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180 PACKAGING AND LABELING exposure
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182 PACKAGING AND LABELING In many
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184 PACKAGING AND LABELING Nonpharm
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186 PACKAGING AND LABELING In 1906,
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188 PACKAGING AND LABELING A medica
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190 PACKAGING AND LABELING The inst
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192 PACKAGING AND LABELING the poun
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194 PACKAGING AND LABELING • (4)
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196 PACKAGING AND LABELING In the c
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198 PACKAGING AND LABELING • Inte
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200 PACKAGING AND LABELING 27. U.S.
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202 CLEAN-FACILITY DESIGN, CONSTRUC
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204 CLEAN-FACILITY DESIGN, CONSTRUC
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206 CLEAN-FACILITY DESIGN, CONSTRUC
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208 CLEAN-FACILITY DESIGN, CONSTRUC
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210 CLEAN-FACILITY DESIGN, CONSTRUC
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212 CLEAN-FACILITY DESIGN, CONSTRUC
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214 CLEAN-FACILITY DESIGN, CONSTRUC
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216 CLEAN-FACILITY DESIGN, CONSTRUC
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218 CLEAN-FACILITY DESIGN, CONSTRUC
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220 CLEAN-FACILITY DESIGN, CONSTRUC
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222 CLEAN-FACILITY DESIGN, CONSTRUC
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224 CLEAN-FACILITY DESIGN, CONSTRUC
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226 CLEAN-FACILITY DESIGN, CONSTRUC
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228 CLEAN-FACILITY DESIGN, CONSTRUC
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230 CLEAN-FACILITY DESIGN, CONSTRUC
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232 CLEAN-FACILITY DESIGN, CONSTRUC
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4.1 SOLID DOSAGE FORMS Barbara R. C
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TABLE 2 Types of Solid Dosage Form
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(GI) tract or for systemic effects.
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EXCIPIENTS IN SOLID DOSE FORMULATIO
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EXCIPIENTS IN SOLID DOSE FORMULATIO
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HARD AND SOFT GELATIN CAPSULES 245
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HARD AND SOFT GELATIN CAPSULES 247
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HARD AND SOFT GELATIN CAPSULES 249
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participants from the FDA, industry
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in the mouth. Compressed lozenges (
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ittle fi lm, have no unpleasant tas
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CHEWING GUMS 257 4.1.10.2 Manufactu
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already dissolved in the saliva pri
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ORALLY DISINTEGRATING TABLETS 261 a
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tions. Some buccal formulations hav
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REFERENCES 265 32. Habib , W. , Kha
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268 SEMISOLID DOSAGES: OINTMENTS, C
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270 SEMISOLID DOSAGES: OINTMENTS, C
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272 SEMISOLID DOSAGES: OINTMENTS, C
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274 SEMISOLID DOSAGES: OINTMENTS, C
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276 SEMISOLID DOSAGES: OINTMENTS, C
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278 SEMISOLID DOSAGES: OINTMENTS, C
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280 SEMISOLID DOSAGES: OINTMENTS, C
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282 SEMISOLID DOSAGES: OINTMENTS, C
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284 SEMISOLID DOSAGES: OINTMENTS, C
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286 SEMISOLID DOSAGES: OINTMENTS, C
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288 SEMISOLID DOSAGES: OINTMENTS, C
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290 SEMISOLID DOSAGES: OINTMENTS, C
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292 SEMISOLID DOSAGES: OINTMENTS, C
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294 SEMISOLID DOSAGES: OINTMENTS, C
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296 SEMISOLID DOSAGES: OINTMENTS, C
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298 SEMISOLID DOSAGES: OINTMENTS, C
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300 SEMISOLID DOSAGES: OINTMENTS, C
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302 SEMISOLID DOSAGES: OINTMENTS, C
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304 SEMISOLID DOSAGES: OINTMENTS, C
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306 SEMISOLID DOSAGES: OINTMENTS, C
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308 SEMISOLID DOSAGES: OINTMENTS, C
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310 SEMISOLID DOSAGES: OINTMENTS, C
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312 SEMISOLID DOSAGES: OINTMENTS, C
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314 LIQUID DOSAGE FORMS 4.3.1 INTRO
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316 LIQUID DOSAGE FORMS 4.3.2 GENER
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318 LIQUID DOSAGE FORMS design, bui
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320 LIQUID DOSAGE FORMS tions with
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322 LIQUID DOSAGE FORMS Dosing Pump
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324 LIQUID DOSAGE FORMS However, th
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326 LIQUID DOSAGE FORMS Location of
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328 LIQUID DOSAGE FORMS Solid drugs
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330 LIQUID DOSAGE FORMS TABLE 3 Emu
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332 LIQUID DOSAGE FORMS Temperature
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334 LIQUID DOSAGE FORMS for viscosi
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336 LIQUID DOSAGE FORMS spectrum, s
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338 LIQUID DOSAGE FORMS Product Spe
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340 LIQUID DOSAGE FORMS Liquid, Ext
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342 LIQUID DOSAGE FORMS 7. Kourouna
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344 LIQUID DOSAGE FORMS 46. Miller
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5.1 CONTROLLED - RELEASE DOSAGE FOR
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CONTROLLED-RELEASE DRUG DELIVERY SY
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CONTROLLED-RELEASE FORMULATIONS 351
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dosage forms [12] . For example, or
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Degradation Liver Hydrolytic Enzyma
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CONTROLLED-RELEASE ORAL DOSAGE FORM
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DESIGN AND FABRICATION OF CONTROLLE
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DESIGN AND FABRICATION OF CONTROLLE
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DESIGN AND FABRICATION OF CONTROLLE
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DESIGN AND FABRICATION OF CONTROLLE
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TECHNOLOGIES FOR DEVELOPING TRANSDE
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TECHNOLOGIES FOR DEVELOPING TRANSDE
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RELEASE OF DRUGS FROM CONTROLLED-RE
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RELEASE OF DRUGS FROM CONTROLLED-RE
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RELEASE OF DRUGS FROM CONTROLLED-RE
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RELEASE OF DRUGS FROM CONTROLLED-RE
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RELEASE OF DRUGS FROM CONTROLLED-RE
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RELEASE OF DRUGS FROM CONTROLLED-RE
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RELEASE OF DRUGS FROM CONTROLLED-RE
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RELEASE OF DRUGS FROM CONTROLLED-RE
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REFERENCES 387 16. Anal , A. K. ( 2
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REFERENCES 389 57. M ü ller , R. H
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REFERENCES 391 96. Sungthongjeen ,
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5.2 PROGRESS IN DESIGN OF BIODEGRAD
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INTRODUCTION 395 sequences. In addi
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TABLE 2 Injectable Peptide/Proteins
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PEPTIDE/PROTEIN-LOADED MICROSPHERE
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PEPTIDE/PROTEIN-LOADED MICROSPHERE
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PEPTIDE/PROTEIN-LOADED MICROSPHERE
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ANALYTICAL CHARACTERIZATION 405 imm
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IMMUNE SYSTEM INTERACTION WITH INJE
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INJECTABLE PEPTIDE/PROTEIN-LOADED M
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INJECTABLE PEPTIDE/PROTEIN-LOADED M
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INJECTABLE PEPTIDE/PROTEIN-LOADED M
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INJECTABLE PEPTIDE/PROTEIN-LOADED M
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INJECTABLE PEPTIDE/PROTEIN-LOADED M
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PEPTIDE/PROTEIN ENCAPSULATED INTO B
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PEPTIDE/PROTEIN ENCAPSULATED INTO B
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PEPTIDE/PROTEIN ENCAPSULATED INTO B
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PEPTIDE/PROTEIN ENCAPSULATED INTO B
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REFERENCES 427 novel ways to reduce
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REFERENCES 429 31. Morlock , M. , K
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REFERENCES 431 63. Lam , X. M. , Du
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REFERENCES 433 95. van de Weert , M
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REFERENCES 435 130. Bilati , U. , A
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REFERENCES 437 166. Means , G. E. ,
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REFERENCES 439 bic poly(lactide -co
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REFERENCES 441 237. Singh , M. , Li
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444 LIPOSOMES AND DRUG DELIVERY (sm
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446 LIPOSOMES AND DRUG DELIVERY Con
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448 LIPOSOMES AND DRUG DELIVERY and
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450 LIPOSOMES AND DRUG DELIVERY tec
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452 LIPOSOMES AND DRUG DELIVERY 250
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454 LIPOSOMES AND DRUG DELIVERY a s
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456 LIPOSOMES AND DRUG DELIVERY For
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458 LIPOSOMES AND DRUG DELIVERY con
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460 LIPOSOMES AND DRUG DELIVERY The
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462 LIPOSOMES AND DRUG DELIVERY in
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464 LIPOSOMES AND DRUG DELIVERY c a
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466 LIPOSOMES AND DRUG DELIVERY Eve
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468 LIPOSOMES AND DRUG DELIVERY inc
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470 LIPOSOMES AND DRUG DELIVERY wit
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472 LIPOSOMES AND DRUG DELIVERY i.v
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474 LIPOSOMES AND DRUG DELIVERY for
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476 LIPOSOMES AND DRUG DELIVERY bet
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478 LIPOSOMES AND DRUG DELIVERY cli
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480 LIPOSOMES AND DRUG DELIVERY lea
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482 LIPOSOMES AND DRUG DELIVERY Vag
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484 LIPOSOMES AND DRUG DELIVERY TAB
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486 LIPOSOMES AND DRUG DELIVERY thr
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488 LIPOSOMES AND DRUG DELIVERY TAB
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490 LIPOSOMES AND DRUG DELIVERY tar
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492 LIPOSOMES AND DRUG DELIVERY tha
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494 LIPOSOMES AND DRUG DELIVERY wit
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496 LIPOSOMES AND DRUG DELIVERY Pul
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498 LIPOSOMES AND DRUG DELIVERY whi
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500 LIPOSOMES AND DRUG DELIVERY Inc
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502 LIPOSOMES AND DRUG DELIVERY Per
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504 LIPOSOMES AND DRUG DELIVERY can
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506 LIPOSOMES AND DRUG DELIVERY Tum
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508 LIPOSOMES AND DRUG DELIVERY 25.
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510 LIPOSOMES AND DRUG DELIVERY 60.
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512 LIPOSOMES AND DRUG DELIVERY 97.
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514 LIPOSOMES AND DRUG DELIVERY 136
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516 LIPOSOMES AND DRUG DELIVERY 170
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518 LIPOSOMES AND DRUG DELIVERY 202
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520 LIPOSOMES AND DRUG DELIVERY 237
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522 LIPOSOMES AND DRUG DELIVERY 271
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524 LIPOSOMES AND DRUG DELIVERY 310
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526 LIPOSOMES AND DRUG DELIVERY 346
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528 LIPOSOMES AND DRUG DELIVERY 378
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530 LIPOSOMES AND DRUG DELIVERY 408
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532 LIPOSOMES AND DRUG DELIVERY 437
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5.4 BIODEGRADABLE NANOPARTICLES Sud
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NATURAL BIODEGRADABLE POLYMERIC NAN
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NATURAL BIODEGRADABLE POLYMERIC NAN
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NATURAL BIODEGRADABLE POLYMERIC NAN
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and drug loading of gliadin nanopar
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SYNTHETIC BIODEGRADABLE POLYMERIC N
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APPLICATIONS OF BIODEGRADABLE NANOP
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PHYSICOCHEMICAL CHARACTERIZATION OF
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TARGETING NANOPARTICLES BY SURFACE
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5.4.9 CONCLUSIONS Biodegradable nan
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REFERENCES 555 of a model protein (
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REFERENCES 557 65. Kaul , G. , and
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REFERENCES 559 99. Carino , G. P. ,
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REFERENCES 561 133. Na , K. , Lee ,
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REFERENCES 563 168. Freitas , C. ,
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5.5 RECOMBINANT SACCHAROMYCES CEREV
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Potential Medical Applications of B
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BIODRUG CONCEPT USING YEAST AS VECT
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BIODRUG CONCEPT USING YEAST AS VECT
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Cumulative ileal delivery of viable
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tine [30] . No signal was detectabl
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ORAL FORMULATION OF RECOMBINANT YEA
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Cumulative ileal delivery of viable
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ORAL FORMULATION OF RECOMBINANT YEA
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Viable yeasts released (% of initia
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Steidler et al. [47] have already d
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REFERENCES 587 23. Steidler , L. (
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REFERENCES 589 nant yeasts as novel
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5.6 NASAL DELIVERY OF PEPTIDE AND N
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fi rst - pass metabolism and gut -
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[6] . The nasal blood vessels can b
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FACTORS INFLUENCING NASAL DRUG ABSO
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5.6.3.6 Type of Delivery Device FAC
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FACTORS INFLUENCING NASAL DRUG ABSO
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FIGURE 4 ( a ) Optinose multidose l
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Dogs, sheep, and monkeys can be kep
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NASAL DELIVERY OF PEPTIDE AND HIGH-
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NASAL DELIVERY OF PEPTIDE AND HIGH-
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NASAL DELIVERY OF PEPTIDE AND HIGH-
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NASAL DELIVERY OF PEPTIDE AND HIGH-
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NASAL DELIVERY OF PEPTIDE AND HIGH-
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in solutions containing different c
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NASAL DELIVERY OF PEPTIDE AND HIGH-
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NASAL DELIVERY OF PEPTIDE AND HIGH-
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Morphine plasma concentration (nmol
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Concentration (μg/L) 1000 100 10 1
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NASAL DELIVERY OF NONPEPTIDE MOLECU
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NASAL DELIVERY OF NONPEPTIDE MOLECU
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OPTION FOR DELIVERY OF DRUGS TO CEN
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pseudostratifi ed epithelium compri
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NASAL DELIVERY OF VACCINES 635 Howe
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TABLE 5 Continued Delivery System/A
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REFERENCES 639 23. Hardy , J. G. ,
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REFERENCES 641 60. Collens , W. S.
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REFERENCES 643 97. Eden , S. ( 1979
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REFERENCES 645 comparison with oral
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REFERENCES 647 172. Sakane , T. , A
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REFERENCES 649 213. McCluskie , M.
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5.7 NASAL POWDER DRUG DELIVERY Jele
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NASAL DRY POWDER FORMULATIONS 653 t
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POLYMERS IN NASAL POWDER DELIVERY S
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POLYMERS IN NASAL POWDER DELIVERY S
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MICROSPHERES AS NASAL DRUG DELIVERY
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MICROSPHERES AS NASAL DRUG DELIVERY
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MICROSPHERES AS NASAL DRUG DELIVERY
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MICROSPHERES AS NASAL DRUG DELIVERY
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TOXICOLOGICAL CONSIDERATIONS 667 et
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Summary of Research Work on Nasal D
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Powder Formulation Preparation Meth
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Powder Formulation Preparation Meth
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REFERENCES 675 19. Van der Lubben ,
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REFERENCES 677 54. Witschi , C. , a
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REFERENCES 679 91. Varshosaz , J. ,
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REFERENCES 681 126. Jorissen , M. ,
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684 AEROSOL DRUG DELIVERY 5.8.8 5.8
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686 AEROSOL DRUG DELIVERY other sig
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688 AEROSOL DRUG DELIVERY are a num
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690 AEROSOL DRUG DELIVERY 5.8.5 MET
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692 AEROSOL DRUG DELIVERY TABLE 1 S
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694 AEROSOL DRUG DELIVERY valve siz
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696 AEROSOL DRUG DELIVERY Ferrule U
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698 AEROSOL DRUG DELIVERY 5.8.5.6 A
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700 AEROSOL DRUG DELIVERY 5.8.5.10
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702 AEROSOL DRUG DELIVERY low inter
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704 AEROSOL DRUG DELIVERY Transpare
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706 AEROSOL DRUG DELIVERY of the cl
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708 AEROSOL DRUG DELIVERY is achiev
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710 AEROSOL DRUG DELIVERY Aerosol g
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712 AEROSOL DRUG DELIVERY REFERENCE
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714 AEROSOL DRUG DELIVERY 42. Witek
- Page 732 and 733:
716 AEROSOL DRUG DELIVERY 81. Ohmor
- Page 734 and 735:
718 AEROSOL DRUG DELIVERY 119. Lewi
- Page 736 and 737:
720 AEROSOL DRUG DELIVERY 153. Terz
- Page 738 and 739:
722 AEROSOL DRUG DELIVERY 189. Sham
- Page 740 and 741:
724 AEROSOL DRUG DELIVERY 225. Newh
- Page 742 and 743:
726 AEROSOL DRUG DELIVERY 263. Dolo
- Page 745 and 746:
5.9 OCULAR DRUG DELIVERY Ilva D. Ru
- Page 747 and 748:
CHALLENGES IN OCULAR DRUG DELIVERY
- Page 749 and 750:
CHALLENGES IN OCULAR DRUG DELIVERY
- Page 751 and 752:
CHALLENGES IN OCULAR DRUG DELIVERY
- Page 753 and 754:
FORMULATION APPROACHES TO IMPROVE O
- Page 755 and 756:
FORMULATION APPROACHES TO IMPROVE O
- Page 757 and 758:
Drug Fluorescein FORMULATION APPROA
- Page 759 and 760:
FORMULATION APPROACHES TO IMPROVE O
- Page 761 and 762:
FORMULATION APPROACHES TO IMPROVE O
- Page 763 and 764:
FORMULATION APPROACHES TO IMPROVE O
- Page 765 and 766:
FORMULATION APPROACHES TO IMPROVE O
- Page 767 and 768:
FORMULATION APPROACHES TO IMPROVE O
- Page 769 and 770:
is characterized by a transient ove
- Page 771 and 772:
REFERENCES 755 11. Klyce , S. D. ,
- Page 773 and 774:
REFERENCES 757 53. Saettone , M. F.
- Page 775 and 776:
REFERENCES 759 87. Lin , H. R. , an
- Page 777 and 778:
REFERENCES 761 122. Durrani , A. M.
- Page 779 and 780:
REFERENCES 763 158. Weyenberg , W.
- Page 781 and 782:
REFERENCES 765 of various ophthalmi
- Page 783:
REFERENCES 767 233. Grass , G. M. ,
- Page 786 and 787:
770 MICROEMULSIONS AS DRUG DELIVERY
- Page 788 and 789:
772 MICROEMULSIONS AS DRUG DELIVERY
- Page 790 and 791:
774 MICROEMULSIONS AS DRUG DELIVERY
- Page 792 and 793:
776 MICROEMULSIONS AS DRUG DELIVERY
- Page 794 and 795:
778 MICROEMULSIONS AS DRUG DELIVERY
- Page 796 and 797:
780 MICROEMULSIONS AS DRUG DELIVERY
- Page 798 and 799:
782 MICROEMULSIONS AS DRUG DELIVERY
- Page 800 and 801:
784 MICROEMULSIONS AS DRUG DELIVERY
- Page 802 and 803:
786 MICROEMULSIONS AS DRUG DELIVERY
- Page 804 and 805:
788 MICROEMULSIONS AS DRUG DELIVERY
- Page 806 and 807:
790 MICROEMULSIONS AS DRUG DELIVERY
- Page 808 and 809:
792 MICROEMULSIONS AS DRUG DELIVERY
- Page 810 and 811:
794 TRANSDERMAL DRUG DELIVERY 5.11.
- Page 812 and 813:
796 TRANSDERMAL DRUG DELIVERY conta
- Page 814 and 815:
798 TRANSDERMAL DRUG DELIVERY 5.11.
- Page 816 and 817:
800 TRANSDERMAL DRUG DELIVERY FIGUR
- Page 818 and 819:
802 TRANSDERMAL DRUG DELIVERY a rat
- Page 820 and 821:
804 TRANSDERMAL DRUG DELIVERY passi
- Page 822 and 823:
806 TRANSDERMAL DRUG DELIVERY 19. E
- Page 825 and 826:
5.12 VAGINAL DRUG DELIVERY Jos é d
- Page 827 and 828:
Therefore, this chapter discusses t
- Page 829 and 830:
THE HUMAN VAGINA 813 thetic innerva
- Page 831 and 832:
THE HUMAN VAGINA 815 the upper repr
- Page 833 and 834:
THE HUMAN VAGINA 817 tant in the re
- Page 835 and 836:
GENERAL FEATURES OF VAGINAL DRUG DE
- Page 837 and 838:
Although this strategy may enhance
- Page 839 and 840:
VAGINAL DRUG DELIVERY SYSTEMS 823 a
- Page 841 and 842:
VAGINAL DRUG DELIVERY SYSTEMS 825 f
- Page 843 and 844:
VAGINAL DRUG DELIVERY SYSTEMS 827 f
- Page 845 and 846:
Amount released, μg/day 800 700 60
- Page 847 and 848:
VAGINAL DRUG DELIVERY SYSTEMS 831 5
- Page 849 and 850:
TABLE 4 Examples of Mucoadhesive Po
- Page 851 and 852:
VAGINAL DRUG DELIVERY SYSTEMS 835 i
- Page 853 and 854:
PHARMACEUTICAL EVALUATION OF VAGINA
- Page 855 and 856:
PHARMACEUTICAL EVALUATION OF VAGINA
- Page 857 and 858:
PHARMACEUTICAL EVALUATION OF VAGINA
- Page 859 and 860:
CLINICAL USAGE AND POTENTIAL OF VAG
- Page 861 and 862:
CLINICAL USAGE AND POTENTIAL OF VAG
- Page 863 and 864:
CLINICAL USAGE AND POTENTIAL OF VAG
- Page 865 and 866:
CLINICAL USAGE AND POTENTIAL OF VAG
- Page 867 and 868:
CLINICAL USAGE AND POTENTIAL OF VAG
- Page 869 and 870:
TABLE 6 Selected Drugs Administered
- Page 871 and 872:
Selected Veterinary Vaginal Drug De
- Page 873 and 874:
REFERENCES 857 Much work remains to
- Page 875 and 876:
REFERENCES 859 33. Hocini , H. , Ba
- Page 877 and 878:
REFERENCES 861 70. Kristmundsdottir
- Page 879 and 880:
REFERENCES 863 105. McClelland , R.
- Page 881 and 882:
REFERENCES 865 141. Kuyoh , M. A. ,
- Page 883 and 884:
REFERENCES 867 178. Ondracek , J. ,
- Page 885 and 886:
REFERENCES 869 212. Bagga , R. , Ra
- Page 887 and 888:
REFERENCES 871 244. International W
- Page 889 and 890:
REFERENCES 873 276. Mor , E. , Saad
- Page 891 and 892:
REFERENCES 875 310. Saltzman , W. M
- Page 893 and 894:
REFERENCES 877 vaginal microbicides
- Page 895:
SECTION 6 TABLET PRODUCTION
- Page 898 and 899:
882 PHARMACEUTICAL PREFORMULATION 6
- Page 900 and 901:
884 PHARMACEUTICAL PREFORMULATION E
- Page 902 and 903:
886 PHARMACEUTICAL PREFORMULATION T
- Page 904 and 905:
888 PHARMACEUTICAL PREFORMULATION T
- Page 906 and 907:
890 PHARMACEUTICAL PREFORMULATION T
- Page 908 and 909:
892 PHARMACEUTICAL PREFORMULATION p
- Page 910 and 911:
894 PHARMACEUTICAL PREFORMULATION T
- Page 912 and 913:
896 PHARMACEUTICAL PREFORMULATION T
- Page 914 and 915:
898 PHARMACEUTICAL PREFORMULATION l
- Page 916 and 917:
900 PHARMACEUTICAL PREFORMULATION T
- Page 918 and 919:
902 PHARMACEUTICAL PREFORMULATION s
- Page 920 and 921:
904 PHARMACEUTICAL PREFORMULATION C
- Page 922 and 923:
906 PHARMACEUTICAL PREFORMULATION p
- Page 924 and 925:
908 PHARMACEUTICAL PREFORMULATION C
- Page 926 and 927:
910 PHARMACEUTICAL PREFORMULATION T
- Page 928 and 929:
912 PHARMACEUTICAL PREFORMULATION D
- Page 930 and 931:
914 PHARMACEUTICAL PREFORMULATION C
- Page 932 and 933:
916 PHARMACEUTICAL PREFORMULATION u
- Page 934 and 935:
918 PHARMACEUTICAL PREFORMULATION d
- Page 936 and 937:
920 PHARMACEUTICAL PREFORMULATION q
- Page 938 and 939:
922 PHARMACEUTICAL PREFORMULATION w
- Page 940 and 941:
924 PHARMACEUTICAL PREFORMULATION C
- Page 942 and 943: 926 PHARMACEUTICAL PREFORMULATION T
- Page 944 and 945: 928 PHARMACEUTICAL PREFORMULATION a
- Page 946 and 947: 930 PHARMACEUTICAL PREFORMULATION a
- Page 949 and 950: 6.2 ROLE OF PREFORMULATION IN DEVEL
- Page 951 and 952: maceutics ” documentation forms a
- Page 953 and 954: e altered without any change in the
- Page 955 and 956: Solubility Heat flow II I T m,II Ts
- Page 957 and 958: TABLE 2 Techniques to Characterize
- Page 959 and 960: Percent weight loss Heat flow (a) (
- Page 961 and 962: Heat flow Intensity 100 50 Endother
- Page 963 and 964: Change in mass (%) PHYSICAL/BULK CH
- Page 965 and 966: 6.2.2.6 Powder Flow and Compressibi
- Page 967 and 968: Solvent required for 1 gm of solid
- Page 969 and 970: ⎧ 100 ⎪ Ka 1+10 Percent ionized
- Page 971 and 972: Percent Ionization Percent Ionizati
- Page 973 and 974: SOLUBILITY CHARACTERISTICS 957 para
- Page 975 and 976: SOLUBILITY CHARACTERISTICS 959 of p
- Page 977 and 978: Dissolution studies pH solubility p
- Page 979 and 980: High Permeability Low SOLUBILITY CH
- Page 981 and 982: is evident form the fact [51] that
- Page 983 and 984: independent of initial drug concent
- Page 985 and 986: STABILITY CHARACTERISTICS 969 drug
- Page 987 and 988: 6.2.5 CONCLUSIONS Preformulation te
- Page 989 and 990: REFERENCES 973 16. Huang , L. , and
- Page 991: 54. 55. 56. REFERENCES 975 IFAMA (
- Page 995 and 996: TABLETING CYCLE 979 The eccentric p
- Page 997 and 998: FIGURE 4 (a) (b) (c) TABLETING CYCL
- Page 999 and 1000: TABLE 1 mm 3 4 5 6 7 8 9 10 11 12 1
- Page 1001 and 1002: LIMITATIONS FOR DIRECT COMPRESSION
- Page 1003 and 1004: Drug release (%) 120 100 80 60 40 2
- Page 1005 and 1006: Beta Carotene Tablets (15 mg ) Form
- Page 1007 and 1008: Lisinopril release (%) FIGURE 10 BI
- Page 1009 and 1010: that do not compress well after wet
- Page 1011 and 1012: Calcium phosphate, dibasic offers h
- Page 1013 and 1014: FIGURE 11 Theophylline release (%)
- Page 1015 and 1016: TABLET DESIGN WITH NATURAL PRODUCTS
- Page 1017 and 1018: TABLE 7 Two Formulations for mangif
- Page 1019 and 1020: TABLE 8 Weight Assay Disintegration
- Page 1021 and 1022: TABLET DESIGN WITH NATURAL PRODUCTS
- Page 1023 and 1024: has a regulatory effect upon the an
- Page 1025 and 1026: DESIGN TOOLS OF TABLET FORMULATION
- Page 1027 and 1028: Amount released PPL (%) 110 100 90
- Page 1029 and 1030: DESIGN TOOLS OF TABLET FORMULATION
- Page 1031 and 1032: Percolation threshold (ε c) FIGURE
- Page 1033 and 1034: 6.3.8 COATING SYSTEMS COATING SYSTE
- Page 1035 and 1036: COATING SYSTEMS 1019 ences between
- Page 1037 and 1038: Water absorption, % 8 7 6 5 4 3 2 1
- Page 1039 and 1040: FIGURE 28 white. mg/h·m 0.9 0.8 0.
- Page 1041 and 1042: (a) (b) FIGURE 31 ( a ) Tablet coat
- Page 1043 and 1044:
TABLE 18 Solid content Batch size,
- Page 1045 and 1046:
Percent released FIGURE 35 Tablet b
- Page 1047 and 1048:
PHARMACEUTICAL TABLETS USING PERCOL
- Page 1049 and 1050:
TABLE 23 Calculation of Tablet Prop
- Page 1051 and 1052:
PHARMACEUTICAL TABLETS USING PERCOL
- Page 1053 and 1054:
PHARMACEUTICAL TABLETS USING PERCOL
- Page 1055 and 1056:
TABLE 25 Aspect Ratios and Exponent
- Page 1057 and 1058:
K H (%min - 1/2)/% v/v excipient pl
- Page 1059 and 1060:
6.3.10 ULTRASOUND-ASSISTED TABLETIN
- Page 1061 and 1062:
ULTRASOUND-ASSISTED TABLETING (A NE
- Page 1063 and 1064:
REFERENCES 1047 18. S á nchez , G.
- Page 1065 and 1066:
REFERENCES 1049 54. Hess , H. , and
- Page 1067:
92. Mill á n , M. , and Caraballo
- Page 1070 and 1071:
1054 TABLET PRODUCTION SYSTEMS 6.4.
- Page 1072 and 1073:
1056 TABLET PRODUCTION SYSTEMS comp
- Page 1074 and 1075:
1058 TABLET PRODUCTION SYSTEMS and
- Page 1076 and 1077:
1060 TABLET PRODUCTION SYSTEMS FIGU
- Page 1078 and 1079:
1062 TABLET PRODUCTION SYSTEMS FIGU
- Page 1080 and 1081:
1064 TABLET PRODUCTION SYSTEMS FIGU
- Page 1082 and 1083:
1066 TABLET PRODUCTION SYSTEMS when
- Page 1084 and 1085:
1068 TABLET PRODUCTION SYSTEMS die
- Page 1086 and 1087:
1070 TABLET PRODUCTION SYSTEMS FIGU
- Page 1088 and 1089:
1072 TABLET PRODUCTION SYSTEMS TABL
- Page 1090 and 1091:
1074 TABLET PRODUCTION SYSTEMS Pres
- Page 1092 and 1093:
1076 TABLET PRODUCTION SYSTEMS Forc
- Page 1094 and 1095:
1078 TABLET PRODUCTION SYSTEMS In(1
- Page 1096 and 1097:
1080 TABLET PRODUCTION SYSTEMS In[1
- Page 1098 and 1099:
1082 TABLET PRODUCTION SYSTEMS [78,
- Page 1100 and 1101:
1084 TABLET PRODUCTION SYSTEMS FIGU
- Page 1102 and 1103:
1086 TABLET PRODUCTION SYSTEMS When
- Page 1104 and 1105:
1088 TABLET PRODUCTION SYSTEMS 3. P
- Page 1106 and 1107:
1090 TABLET PRODUCTION SYSTEMS 44.
- Page 1108 and 1109:
1092 TABLET PRODUCTION SYSTEMS 81.
- Page 1110 and 1111:
1094 TABLET PRODUCTION SYSTEMS 119.
- Page 1112 and 1113:
1096 TABLET PRODUCTION SYSTEMS 160.
- Page 1114 and 1115:
1098 TABLET PRODUCTION SYSTEMS 197.
- Page 1116 and 1117:
1100 CONTROLLED RELEASE OF DRUGS FR
- Page 1118 and 1119:
1102 CONTROLLED RELEASE OF DRUGS FR
- Page 1120 and 1121:
1104 CONTROLLED RELEASE OF DRUGS FR
- Page 1122 and 1123:
1106 CONTROLLED RELEASE OF DRUGS FR
- Page 1124 and 1125:
1108 CONTROLLED RELEASE OF DRUGS FR
- Page 1126 and 1127:
1110 CONTROLLED RELEASE OF DRUGS FR
- Page 1128 and 1129:
1112 CONTROLLED RELEASE OF DRUGS FR
- Page 1130 and 1131:
1114 CONTROLLED RELEASE OF DRUGS FR
- Page 1132 and 1133:
1116 CONTROLLED RELEASE OF DRUGS FR
- Page 1134 and 1135:
1118 CONTROLLED RELEASE OF DRUGS FR
- Page 1136 and 1137:
1120 CONTROLLED RELEASE OF DRUGS FR
- Page 1138 and 1139:
1122 CONTROLLED RELEASE OF DRUGS FR
- Page 1140 and 1141:
1124 CONTROLLED RELEASE OF DRUGS FR
- Page 1142 and 1143:
1126 CONTROLLED RELEASE OF DRUGS FR
- Page 1144 and 1145:
1128 CONTROLLED RELEASE OF DRUGS FR
- Page 1146 and 1147:
1130 CONTROLLED RELEASE OF DRUGS FR
- Page 1148 and 1149:
1132 CONTROLLED RELEASE OF DRUGS FR
- Page 1150 and 1151:
1134 TABLET COMPRESSION stages invo
- Page 1152 and 1153:
1136 TABLET COMPRESSION although on
- Page 1154 and 1155:
1138 TABLET COMPRESSION P P = + C a
- Page 1156 and 1157:
1140 TABLET COMPRESSION 4. Estimati
- Page 1158 and 1159:
1142 TABLET COMPRESSION from a hopp
- Page 1160 and 1161:
1144 TABLET COMPRESSION speed of th
- Page 1162 and 1163:
1146 TABLET COMPRESSION FIGURE 4 Co
- Page 1164 and 1165:
1148 TABLET COMPRESSION FIGURE 5 Id
- Page 1166 and 1167:
1150 TABLET COMPRESSION its low tou
- Page 1168 and 1169:
1152 TABLET COMPRESSION Standard TS
- Page 1170 and 1171:
1154 TABLET COMPRESSION A B C D E F
- Page 1172 and 1173:
1156 TABLET COMPRESSION Top view Pr
- Page 1174 and 1175:
1158 TABLET COMPRESSION particle si
- Page 1176 and 1177:
1160 TABLET COMPRESSION 6.6.10.3 Mo
- Page 1178 and 1179:
1162 TABLET COMPRESSION 7. Masteau
- Page 1181 and 1182:
6.7 EFFECTS OF GRINDING IN PHARMACE
- Page 1183 and 1184:
MILLING EQUIPMENT 1167 whereas smal
- Page 1185 and 1186:
Screen Product FIGURE 3 Hammers Ham
- Page 1187 and 1188:
inders, disintegrants, glidants, lu
- Page 1189 and 1190:
Airflow Press POWDER CHARACTERIZATI
- Page 1191 and 1192:
Powder flow Sample Process stream (
- Page 1193 and 1194:
Container 1 Container 1 Discard (a)
- Page 1195 and 1196:
Porous particles in container POWDE
- Page 1197 and 1198:
POWDER CHARACTERIZATION TECHNIQUES
- Page 1199 and 1200:
expansions or fractal dimensions);
- Page 1201 and 1202:
EFFECT OF PARTICLE SIZE REDUCTION O
- Page 1203 and 1204:
EFFECT OF PARTICLE SIZE REDUCTION O
- Page 1205 and 1206:
REFERENCES 1189 19. British Standar
- Page 1207 and 1208:
6.8 ORAL EXTENDED - RELEASE FORMULA
- Page 1209 and 1210:
INTRODUCTION 1193 line) together wi
- Page 1211 and 1212:
INTRODUCTION 1195 substance) instea
- Page 1213 and 1214:
of the drug particles/formulation a
- Page 1215 and 1216:
M A DCt t = ⎡ ε s ( 2C − C )
- Page 1217 and 1218:
method for insoluble matrix tablets
- Page 1219 and 1220:
MEMBRANE-COATED ORAL EXTENDED RELEA
- Page 1221 and 1222:
MEMBRANE-COATED ORAL EXTENDED RELEA
- Page 1223 and 1224:
Swelling front Diffusion front Eros
- Page 1225 and 1226:
dM Q = ∫ dt = kt 0 dt HYDROPHILIC
- Page 1227 and 1228:
TABLE 2 FDA Registered Oral ER Form
- Page 1229 and 1230:
6.8.6 OTHER ORAL ER FORMULATIONS OT
- Page 1231 and 1232:
REFERENCES 1215 15. Neau , S. H. ,
- Page 1233 and 1234:
REFERENCES 1217 54. Sousa , J. J. ,
- Page 1235 and 1236:
REFERENCES 1219 89. Ford , J. L. ,
- Page 1237 and 1238:
REFERENCES 1221 122. Talukdar , M.
- Page 1239:
SECTION 7 ROLE OF NANOTECHNOLOGY
- Page 1242 and 1243:
1226 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1244 and 1245:
1228 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1246 and 1247:
1230 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1248 and 1249:
1232 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1250 and 1251:
1234 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1252 and 1253:
1236 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1254 and 1255:
1238 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1256 and 1257:
1240 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1258 and 1259:
1242 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1260 and 1261:
1244 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1262 and 1263:
1246 CYCLODEXTRIN-BASED NANOMATERIA
- Page 1265 and 1266:
7.2 NANOTECHNOLOGY IN PHARMACEUTICA
- Page 1267 and 1268:
NANOMATERIALS 1251 tists regard mat
- Page 1269 and 1270:
NANOMATERIALS 1253 TABLE 1 Characte
- Page 1271 and 1272:
NANOMATERIALS 1255 sor molecules/pa
- Page 1273 and 1274:
TABLE 2 Continued Types of Nanomate
- Page 1275 and 1276:
H 3 C CH 3 N + CH 3 O O O O - P O O
- Page 1277 and 1278:
NANOTECHNOLOGY FOR DRUG DELIVERY 12
- Page 1279 and 1280:
entrapped drugs releasing [90] . So
- Page 1281 and 1282:
NANOTECHNOLOGY FOR DRUG DELIVERY 12
- Page 1283 and 1284:
NANOTECHNOLOGY FOR DRUG DELIVERY 12
- Page 1285 and 1286:
NANOTECHNOLOGY FOR DRUG DELIVERY 12
- Page 1287 and 1288:
NANOTECHNOLOGY FOR DRUG DELIVERY 12
- Page 1289 and 1290:
NANOTECHNOLOGY FOR DRUG DELIVERY 12
- Page 1291 and 1292:
NANOTECHNOLOGY FOR DRUG DELIVERY 12
- Page 1293 and 1294:
NANOTECHNOLOGY FOR DRUG DELIVERY 12
- Page 1295 and 1296:
NANOMEDICINE 1279 prises) visibly p
- Page 1297 and 1298:
REFERENCES 1281 16. http://www.whit
- Page 1299 and 1300:
REFERENCES 1283 55. Kam , N. W. S.
- Page 1301 and 1302:
REFERENCES 1285 92. Zhang , J. Q. ,
- Page 1303 and 1304:
REFERENCES 1287 126. Smart , S. K.
- Page 1305 and 1306:
7.3 PHARMACEUTICAL NANOSYSTEMS: MAN
- Page 1307 and 1308:
7.3.2 TAXONOMY OF NANOMEDICINE TECH
- Page 1309 and 1310:
TABLE 1 Continued Molecular medicin
- Page 1311 and 1312:
Applications of quantum dots includ
- Page 1313 and 1314:
7.3.5 MANUFACTURING TECHNOLOGIES Th
- Page 1315 and 1316:
Ratio of hydrodynamic radius, R H ,
- Page 1317 and 1318:
eplicated on the substrate, with na
- Page 1319 and 1320:
MANUFACTURING TECHNOLOGIES 1303 bel
- Page 1321 and 1322:
CHARACTERIZATION TECHNIQUES 1305 TA
- Page 1323 and 1324:
CHARACTERIZATION TECHNIQUES 1307 TA
- Page 1325 and 1326:
Limitations of AFM [255 - 257] Pote
- Page 1327 and 1328:
REFERENCES 1311 thelial cells, the
- Page 1329 and 1330:
REFERENCES 1313 34. Ostrander , K.
- Page 1331 and 1332:
REFERENCES 1315 77. Muangsiri , W.
- Page 1333 and 1334:
REFERENCES 1317 124. Caruso , F. ,
- Page 1335 and 1336:
REFERENCES 1319 170. Rogers , J. A.
- Page 1337 and 1338:
REFERENCES 1321 application: Synthe
- Page 1339 and 1340:
252. Fontaine , P. A. , et al. ( 19
- Page 1341:
Characterization Methods Binks , B.
- Page 1344 and 1345:
1328 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1346 and 1347:
1330 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1348 and 1349:
1332 Application TABLE 1 Selected M
- Page 1350 and 1351:
1334 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1352 and 1353:
1336 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1354 and 1355:
1338 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1356 and 1357:
1340 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1358 and 1359:
1342 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1360 and 1361:
1344 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1362 and 1363:
1346 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1364 and 1365:
1348 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1366 and 1367:
1350 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1368 and 1369:
1352 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1370 and 1371:
1354 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1372 and 1373:
1356 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1374 and 1375:
1358 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1376 and 1377:
1360 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1378 and 1379:
1362 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1380 and 1381:
1364 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1382 and 1383:
1366 OIL-IN-WATER NANOSIZED EMULSIO
- Page 1384 and 1385:
1368 INDEX Cholera toxin, 637 Cilio
- Page 1386:
1370 INDEX Production of radiopharm