Quality control for soft gelatin capsules

Pharmacy

1. Quality Control for Soft Gelatin Capsules Importance of Base Absorption And Minim Per Gram Prepared By- Dinisha Sharma 17HPH044

2. It is the dept. in the Pharmaceutical Company where the quality analyst attempts to determine the concerntration of a specific substance in the sample

3. It is a solid capsule surrounding a liquid or semisolid center. API can be incorporated in the outer shell, inner fill or both Shells of the SGC are combination of gelatin, water, opacifiers and plasticizers Soft Gelatin Capsules

4. Soft gelatin capsules are subjected for following tests during quality control: 1.Shape and size 2.Colour 3.Thickness of the capsule shell 4. Leaking test 5.Disintegration tests 6.Weight variation test 7.Percentage of medicament test Quality Control of Soft Gelatin Capsules

5. To check content uniformity of soft gelatin capsules we need to follow the steps below: Weight the capsules individually Then cut & open the capsules Remove the contents by washing with a suitable solvent Allow the solvent to evaporate from the shells at room temperature Weight the individual shells Calculate the net contents Content Uniformity Test

6. Disintegration test apparatus is used. One capsule is placed in each tube which are suspended in the beakers to move up and down for 30 minutes. The capsule pass the test if no drug or fragments of shell remains on #10 mesh Disintegration test

7. 20 capsules are taken at random and weighed. Average weight is calculated Each capsule is weighed individually and their weight noted. The capsule passes the test if the weight of individual capsule falls within 90-110% of the average weight Weight Variation test

8. The leakage of soft gelatin capsules are determined by following factors- 1.Bloom or gel strength-It is a cohesive strength of cross-linking that occurs between gelatin molecules and is proportional to the mol. wt. 2. Viscosity of gelatin-It is a measure of chain length & manufacturing characterstic of gelatin film 3.Iron content-It is present in raw gelatin as well as water used in manufacture. E xcess qty. of iron can effect the formulation and react with organic compounds Leakeage Test

9. The test is perfomed to find out the integrity of capsule shell. The standard capsule shells are kept at room temperature 40°C and 80% RH becomes more soft, sticky and swollen Stabilty test

10. Base adsorption is expressed as the number of grams of liquid base required to produce a capsulatable mixture when mixed with one gram of solids. The base adsorption of a solid is influenced by such factors The solids particle size and shape, Its physical state Its density Its moisture content, and Its lipophilic or hydrophilic nature The base adsorption is obtained by- weight of the base/weight of the solid = Base Adsorption Base Adsorption of Solids to be suspended in soft gelatin capsules

11. Weight the definite amount(40g is convenient) of the solid substance into a 150ml tared beaker In a separate 150ml tared beaker place 100g of the solid base Add small amount of liquid base into the solid and stir it with spatula until consistent soft ointment is produced Continue to add liquid until the mixture flows steadily from the spatula blade when held at a 45 degree angle above the mixture Calculate the base adsorption using the above given formula Determination of Base Adsorption

12. The base adsoorption is used to determine the “minim per gram” factor (M/g) of the solid(s). The minim per gram factor is the volume in minims that is occupied by one gram of the solid plus the weight of the liquid base(BA) required to make capsulatable mixture. The minim per gram factor is calculated by dividing the weight of the base plus the gram of solid base (BA+S) by the weight of the mixture (W) per cubic centimeter or 16.23 minims (V). (BA+S) x V/W = M/g Thus lower the base absorption of the solids and higher the density of the mixture, the smaller the capsule will be. Minim per gram” FACTOR (M/g) OF THE SOLID