New Trends in Pharmaceutical Compounding - Fagron
New Trends in Pharmaceutical Compounding - Fagron
New Trends in Pharmaceutical Compounding - Fagron
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<strong>New</strong> <strong>Trends</strong> <strong>in</strong><br />
<strong>Pharmaceutical</strong><br />
Compound<strong>in</strong>g<br />
Loyd V. Allen, Jr., Ph.D.<br />
President; International Society of<br />
<strong>Pharmaceutical</strong> Compound<strong>in</strong>g<br />
Editor-<strong>in</strong><br />
<strong>in</strong>-Chief; International Journal of<br />
<strong>Pharmaceutical</strong> Compound<strong>in</strong>g<br />
Outl<strong>in</strong>e<br />
I. <strong>New</strong> <strong>Trends</strong> <strong>in</strong> <strong>Pharmaceutical</strong><br />
Compound<strong>in</strong>g<br />
II.<br />
Future Changes <strong>in</strong> <strong>Pharmaceutical</strong><br />
Compound<strong>in</strong>g<br />
I. <strong>New</strong> <strong>Trends</strong> <strong>in</strong> <strong>Pharmaceutical</strong><br />
Compound<strong>in</strong>g<br />
Liposomes<br />
– Transdermal<br />
– Nails<br />
Films<br />
– Topical<br />
Topical<br />
Sk<strong>in</strong><br />
Nail<br />
Slow Release Capsules<br />
I. <strong>New</strong> <strong>Trends</strong> <strong>in</strong> <strong>Pharmaceutical</strong><br />
Compound<strong>in</strong>g<br />
Pediatric Oral Solids for Reconstitution<br />
WHO Oral Rehydration Powder<br />
Transdermal Patches<br />
Chest Pluronic Gel<br />
Esophageal Pluronic Gel<br />
I. <strong>New</strong> <strong>Trends</strong> <strong>in</strong> <strong>Pharmaceutical</strong><br />
Compound<strong>in</strong>g<br />
Oral Inhalation-eFlow<br />
devices<br />
M<strong>in</strong>iLollipops<br />
M<strong>in</strong>iTroches<br />
Rapidly Dissolv<strong>in</strong>g Tablets<br />
Long-Act<strong>in</strong>g Injections <strong>in</strong> Oil<br />
Nasal Spray-Gels<br />
Gel-Creams<br />
Liposomes, Transdermal<br />
Morph<strong>in</strong>e Sulfate 100mg/mL <strong>in</strong> PLO<br />
– Morph<strong>in</strong>e sulfate<br />
– Propylene glycol<br />
– Lecith<strong>in</strong>:Isopropyl palmitate<br />
– Pluronic 20% gel qs<br />
10 g<br />
10 g<br />
22 mL<br />
100 mL<br />
1
Compounded PLO Gels<br />
Liposomes, , Nails<br />
Psoriasis Nail Treatment<br />
– Ketoprofen<br />
– Cyclospor<strong>in</strong><br />
250 mg<br />
200 mg<br />
– Clobetasol, , micronized 10 mg<br />
– Ethoxy diglycol<br />
– Lecith<strong>in</strong>:isopropyl palmitate<br />
– Pluronic F127 20% gel qs<br />
1 mL<br />
2.2 mL<br />
10 mL<br />
Polymer-based<br />
Films, Oral<br />
Gelat<strong>in</strong>-based<br />
Matrix plus drug: Cast onto smooth<br />
surface<br />
Films, Topical-Sk<strong>in</strong><br />
Films, Topical-Nail<br />
Lurandrenolide Topical Film<br />
– Flurandrenolide<br />
– Polyv<strong>in</strong>yl alcohol<br />
– Povidone<br />
– Glycer<strong>in</strong><br />
– Alcohol<br />
– Benzyl alcohol<br />
– Propylene glycol<br />
– Disodium edetate<br />
– Citric acid<br />
– Purified water<br />
qs<br />
100 mg<br />
9 g<br />
11 g<br />
9 g<br />
10 g<br />
2 g<br />
3 g<br />
20 mg<br />
100 mg<br />
100 mL<br />
Ciclopirox<br />
Ethylcellulose<br />
Alcohol<br />
qs<br />
8 g<br />
3 g<br />
100 mL<br />
2
Slow Release Capsules<br />
Triple Estrogen 2.5 mg SR Capsules<br />
– Estriol<br />
– Estrone<br />
– Estradiol<br />
– Methocel E4M Premium<br />
– Lactose<br />
– Size #1 Capsules<br />
200 mg<br />
25 mg<br />
25 mg<br />
10 g<br />
23.75 g<br />
Pediatric Oral Solids for<br />
Reconstitution<br />
Active drug<br />
Sweetener<br />
Viscosity agent<br />
Smooth<strong>in</strong>g agent/mouthfeel<br />
WHO Oral Rehydration Powder<br />
Transdermal Patches<br />
Sodium chloride<br />
Sodium citrate, anhydrous<br />
Potassium chloride<br />
Glucose, anhydrous<br />
3.6 g<br />
2.9 g<br />
1.5 g<br />
13.5 g<br />
Diclofenac Sodium 1% Soft-Patch Gel<br />
– Diclofenac sodium<br />
– Propylene glycol<br />
– Glycer<strong>in</strong><br />
– Stearic acid<br />
– Sodium hydroxide 10.7% w/v soln.<br />
1 g<br />
50 g<br />
33 g<br />
6 g<br />
soln. 10 mL<br />
Chest Pluronic Gel<br />
Vancomyc<strong>in</strong> Pluronic Gel<br />
– Vancomyc<strong>in</strong> HCl<br />
5 g<br />
– Pluronic F-127 30% gel 1000 mL<br />
– (<strong>in</strong> Sterile water for <strong>in</strong>jection)<br />
3
Esophageal Pluronic Gels<br />
Oral Inhalation M<strong>in</strong>i-Flow Devices<br />
Sucralfate Esophageal Gel<br />
– Sucralfate<br />
5 g<br />
– Pluronic F127 20% gel qs<br />
100 mL<br />
– OR<br />
Misoprostol 0.0024% Esophageal Gel<br />
– Misoprostol<br />
– Pluronic F127 20% gel qs<br />
2.4 mg<br />
100 mL<br />
Gentamic<strong>in</strong> sulfate<br />
0.9% NaCl Solution<br />
qs<br />
10 mg<br />
3 mL<br />
M<strong>in</strong>iLollipops<br />
Compounded Lollipops<br />
Pilocarp<strong>in</strong>e 5 mg M<strong>in</strong>i-Lollipops<br />
– Pilocarp<strong>in</strong>e<br />
– Sorbitol Lollipop base<br />
5 mg<br />
qs<br />
M<strong>in</strong>iTroches<br />
Testosterone 0.5 mg M<strong>in</strong>iTroches<br />
For 100 M<strong>in</strong>itroches<br />
– Testosterone<br />
– PEG Troche base<br />
50 mg<br />
qs<br />
Rapidly Dissolv<strong>in</strong>g Tablets<br />
Homatrop<strong>in</strong>e 3 mg Rapid-Dissolv<strong>in</strong>g<br />
Tablets<br />
For 100 tablets<br />
– Homatrop<strong>in</strong>e HBr<br />
– Mannitol<br />
– Lactose<br />
– Flavor (dry powder type)<br />
– Polyethylene glycol 3350<br />
300 mg<br />
3.5 g<br />
3.5 g<br />
qs<br />
3.5 g<br />
4
Long-Act<strong>in</strong>g Injection <strong>in</strong> Oil<br />
Hydroxyprogesterone Caproate 250<br />
mg/mL <strong>in</strong> Oil Injection<br />
– Hydroxyprogesterone caproate<br />
– Benzyl alcohol<br />
– Benzyl benzoate<br />
– Castor oil or other suitable oil qs<br />
25 g<br />
2 mL<br />
46 mL<br />
100 mL<br />
Nasal Spray-Gel<br />
Fentanyl Citrate 100 mcg/mL<br />
mL Nasal Spray<br />
Gel<br />
– Fentanyl citrate<br />
– Sodium chloride<br />
– Citric acid<br />
– Pluronic F-127<br />
5 g<br />
– Preserved water<br />
qs<br />
16 mg<br />
620 mg<br />
330 mg<br />
100 mL<br />
Gel-Creams<br />
Dexpanthenol 5% Gel-Cream<br />
– Dexpanthenol<br />
– M<strong>in</strong>eral oil<br />
– Polyethylene glycol 400<br />
5 g<br />
10 g<br />
15 g<br />
– Poloxamer F-127<br />
18 g<br />
– Purified water<br />
qs<br />
100 g<br />
III. Future Changes <strong>in</strong><br />
<strong>Pharmaceutical</strong> Compound<strong>in</strong>g<br />
Growth<br />
Official monographs<br />
– Uniform formulations<br />
– Uniform beyond-use dates<br />
Official chapters<br />
– Compound<strong>in</strong>g with hazardous drugs<br />
Quality Standards<br />
Pharmacy Compound<strong>in</strong>g Accreditation<br />
Board and Jo<strong>in</strong>t Commission<br />
Growth<br />
More discont<strong>in</strong>ued drug products<br />
Less drug dosage forms for selection for<br />
patients<br />
More “off-label” use and methods of<br />
adm<strong>in</strong>istration<br />
Lower cost of therapy<br />
BrandsGenerics<br />
GenericsCompounded<br />
Preps<br />
5
Official Monographs<br />
Current emphasis on pediatric<br />
formulations<br />
BHRT<br />
Geriatric<br />
Pa<strong>in</strong> management<br />
Veter<strong>in</strong>ary<br />
Uniform Formulations<br />
Official monographs<br />
Documented beyond-use dates<br />
Patient receives same preparation all over<br />
the US<br />
Uniform Beyond-Use Dates<br />
Nonsterile<br />
Sterile<br />
Documented<br />
Default<br />
Quality Standards<br />
US Pharmacopeia<br />
National Formulary<br />
Food Chemicals Codex<br />
State Boards of Pharmacy<br />
Other<br />
Pharmacy Compound<strong>in</strong>g<br />
Accreditation Board-USA<br />
Higher standards<br />
Emphasis on Standard Operat<strong>in</strong>g<br />
Procedures and documentation<br />
Reviewed every other year<br />
A bright future!<br />
6
..<br />
Thank<br />
You<br />
7
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