SOFT GELETIN CAPSULES

SOFT GELETIN CAPSULES

1. Class- B-pharm- III Sem V Subject - . Industrial Pharmacy- I Topic Name : Soft Gelatin Capsules Mr Nandakishor B Deshmukh. Assistant Professor Department Of Pharmaceutics Shraddha Institute Of Pharmacy, Kondala Zambre , Washim

2. SOFT GELATIN CAPSULES Definition: Soft gelatin capsules are made of gelatin to which glycerin or a polyhydric alcohol such as sorbitol has been added. Soft gelatin capsules, which contain more moisture than hard capsules, may have a preservative, such as methylparaben and/or propylparaben , to retard microbial growth. These are solid dosage forms in which powder, paste, or liquid medicaments are enclosed in a soft, globular gelatin shell. They may be round, oval, or oblong in shape.

3. Nature of Shell and Capsules Contents soft gelatin are made up of gelatin . Gelatin: Plasticizers: Water: Colourants Bloom Strength: Viscosity: Flavouring Agent Sweetening Agent Preservatives

4. Capsule Size Size Volume (ml) Size in mm 000 1.37 26.3 00 0.95 23.7 0.68 21.8 1 0.50 19.2 2 0.37 18.3 3 0.30 15.3 4 0.21 14.7 5 0.13 11.9 For Human use, empty capsules ranging in size from 000 the largest to 5 smallest.

5. Special shapes

6. Tubes

7. Ovals

8. Oblong

9. Importance of Base Adsorption and Minim/gram Importance: It helps to determine base adsorption and fluidity of a mixture. It is used to determine the minim per gram factor (M/g) of the solid. It is also important of establishing specification for the control of physical properties of solid. The convenience of using M/g factors is particularly evident in the vitamin field, where there may be many ingredients and numerous combinations. They are used to rapidly calculate capsules size

10. Ingredients Base BA M/g Acetaminophen Vegetable oil 0.76 25.97 Ascorbic acid Polysorbate 80 1.10 26.92 Lactose Vegetable oil 0.75 23.87 BA and M/g Factors of Some Typical Solids :

11. Production of Soft Gelatin Capsules Composition of the shell: *The basic component of soft gelatin shell is gelatin; however, the shell has been plasticized. The ratio of dry plasticizer to dry gelatin determines the “hardness” of the shell and can vary from 0.3 - 1.0 for very hard shell to 1.0 - 1.8 for very soft shell. Up to 5% of sugar may be included to give a “chewable” quality to the shell.The residual shell moisture content of finished capsules will be in the range of 6-10%.

12. Formulation: Formulation of soft gelatin capsules involves liquid, rather than powder technology. Material are generally formulated to produce the smallest possible capsules consistent with maximum stability, therapeutic effectiveness and manufacture efficiency. The liquid is limited to those that do not have an adverse effect on gelatin shell. The pH of liquid can be in the range 2.5 - 7.5.

13. Soft Gelatin Capsules are manufactured by following four methods: Plate process, Rotary die process, Reciprocating die, Accogel machine .

14. Plate Process: * Place the gelatin sheet over a die plate containing numerous die pockets. * Application of vacuum to draw the sheet in to the die pockets. * Fill the pockets with liquid or paste. * Place another gelatin sheet over the filled pockets, and Sandwich under a die press where the capsules are formed and cut out

15. Rotary Die Process: * In this machine the soft gelatin capsules are prepared and then filled immediately with liquid medicaments, it is having two hoppers and two rotating dies * Liquid mixture is placed in one hopper and the liquid medicament in another Hopper. * The two rotating dies rotate in opposite directions when the fluid gelatin mixture enters the machine from the hopper it produces two continuous ribbons. * These half shells of the capsule are formed. At this stage the measured quantity of the medicament is filled in to it with the stroke of a pump with the subsequent movement of the dies, the other half capsule is formed.

16. Reciprocating Die Process: * The early success of the rotary die process led others to develop continuous methods of soft gelatin capsules manufacture. *One such method, known as the reciprocating die process, was announced in 1949 and was developed by the Nortan Company, Worchester, MA .

17. Quality Control Tests Disintegration Test Weight variation Content Uniformity Dissolution Test Physical Quality Control capsule colour

18. Stability Testing of Soft Gelatin Capsules Moisture Permeation Test: Physical Stability:

19. Applications of Soft Gelatin Tablets As an oral dosage form. As a suppository dosage form. As a specialty package in tube form, for human and veterinary use, single dose application for topical, ophthalmic, and rectal ointments. It is used in water immiscible, volatile, and non-volatile liquid such as vegetable and aromatic oils, aromatic and aliphatic hydrocarbons, ether, esters, alcohol, and organic acids. Solid also encapsulated into soft gelatin capsules as solution in one of the suitable liquid solvent, as suspension, or as dry powder, granules, or pelletized materials.