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Medicinus - Dexa Medica

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38<br />

technology<br />

cal characteristics, for chemical characteristics such<br />

as qualitative and quantitative standardization, and<br />

for potential impurities, and total aerobic microbial<br />

count. All three types of test are relevant at the time<br />

of formulation into dosage forms. The testing of<br />

physical properties of soft extracts determines formulation<br />

into dosage form, and its testing of chemical<br />

properties influencing the method of fabrication.<br />

For the preparation of solid dosage forms mostly<br />

dry extracts are used. Except in rare cases, dry extracts<br />

are hygroscopic and so they cannot be used<br />

without prior granulation for preparing tablets.<br />

Granulation is thus the critical stage in the process of<br />

preparing all solid dosage forms containing extracts.<br />

To overcome the problem of hygroscopic, Aerosil,<br />

a high porosity excipient, is widely used. Further<br />

when operating with wet granulation, it is advisable<br />

to use binders such us cellulose derivatives or polyvinylpirolidon<br />

in solution with organic solvents. If<br />

aqueous solutions of cellulose derivatives, gum arabic,<br />

gelatin, or aqueous gel such as starch mucilage<br />

are used, several problems may arise in the course<br />

of processing, especially if the formulation involves<br />

large quantities of extracts.<br />

The steps required in the preparation of tablets<br />

from soft extracts by wet granulation are shown in<br />

schematic diagram as follows:<br />

Sugar or saponins, frequently present as secondary<br />

components of extracts, dissolve in water used for<br />

mixing and form granules that are difficult to dry during<br />

the drying process, very hard flakes of glassy appearance,<br />

making granules hard to compress. Another<br />

snag found in granulation with aqueous solutions is<br />

the formation of compressed tablets that are difficult<br />

to disintegrate. With dry extracts, after dry mixing with<br />

MEDICINUS 24(1), January 2011<br />

appropriate excipients it is possible to obtain by direct<br />

compression, without further manipulation. In these<br />

cases, tablet obtained are technologically satisfactory<br />

in terms of hardness, friability and disintegration time.<br />

The excipients most commonly used for this purpose<br />

are microcrystalline.<br />

Fluid, soft, or dry extracts may be used for preparing<br />

liquid dosage forms that are undoubtedly far more<br />

difficult to prepare than solid dosage forms. While the<br />

main problem with the latter is the hygroscopic of<br />

the extracts used, with liquid dosage forms there is<br />

the problem of solubility of the extracts. Variation in<br />

the pH can definitely improve the solubility and stability<br />

of some extracts. The stability, both chemical and<br />

physical of a liquid dosage forms is affected by other<br />

factors, for example, the possibility of fermentation<br />

and interference with other component of the finished<br />

product.<br />

CONCLUSION<br />

For the conclusion, it can be noted that: the formulation<br />

and fabrication of phytopharmaceutical into<br />

dosage forms is a complex operation which cannot be<br />

regarded only as a problem of pharmaceutical technology.<br />

It is need more close collaboration between<br />

manufacturer and formulator especially of extract<br />

based products.<br />

The source of manufacturing problems those are<br />

often difficult to solve as the crucial stages in the process<br />

are the choice of raw materials and the procedure<br />

of extraction.<br />

Problems involved in phytopharmaceutical fabrication<br />

depend on the type of dosage forms produced.<br />

It means that for powdered in sachet are focused is on<br />

fluidity and homogeneity combination of raw materials,<br />

for tablets these must be ensure both the fluidity<br />

and compressibility of active substances and pharmaceutical<br />

ingredients used.<br />

Daftar Pustaka<br />

1. Polderman J. Introduction to pharmaceutical production. Novib, The<br />

Hague; 1990<br />

2. Lieberman HA, Lachman L. Pharmaceutical dosage forms, tablets. Vol. 2,<br />

New York & Basel:Marcel Dekker, Inc.; 1985<br />

3. Ansel HC, Popovich NG and Allen LV. Pharmaceutical dosage forms and<br />

drug delivery systems. Lea & Febiger Book. Baltimore, Philadelphia; 1995<br />

4. Bisset NG and Wichtl M. Herbal drugs and phytopharmaceuticals. 2 nd ed.<br />

Stutgart:Medpharm GmbH Scientific Publisher; 2001<br />

5. Brain KR, Turner TD. The practical evaluation of phytopharmaceuticals.<br />

Bristol:Wright-Scientechnica; 1975<br />

6. Wijeskera ROB. The medicinal plant industry. INTECNOS Associates, International;<br />

1991

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