Industrial Pharmacy Lecture 5 PDF

Reciprocating die process of soft gelatin capsules  Product Quality Considerations 1-Ingredient specifications all ingredients of a soft gel are controlled and tested to ensure compliance with pharmacopoeial specifications. E.g. Impurities such...

Reciprocating die process of soft gelatin capsules  Product Quality Considerations 1-Ingredient specifications all ingredients of a soft gel are controlled and tested to ensure compliance with pharmacopoeial specifications. E.g. Impurities such as aldehydes & peroxides which may be present in polyethylene glycols. Presence of high levels of these impurities gives rise to cross-linking of the gelatin polymer, leading to insolubilization through further polymerization. 2-In-process testing During the encapsulation process the four most important tests are:- A) The gel ribbon thickness; B) Soft gel seal thickness at the time of encapsulation; C) Fill matrix weight and capsule shell weight; D) Soft gel shell moisture level and soft gel hardness at the end of the drying stage. 3. Finished product testing These normally includes: 1. Capsule appearance, active ingredient assay & related substances assay 2. Weight variation test 3. Content uniformity test 4. Microbiological testing. 5. Moisture content test. 6. Disintegration test 7. Dissolution test Homewor  Comparison between soft and hard gelatin capsule Hard gelatin capsule Soft gelatin capsule It consist of two part body and cap It becomes one piece after sealing the two halves of capsule They cylindrical in shape They are oval , round , and tube like shape The shell consist of sugar, gelatin and They are consist of gelatin, water and water plasticizer Filled with powder, oily liquid Filled with powder, suspension, paste , liquid or even formulated tablet