SOFT GELATIN CAPSULE : SOFT GELATIN CAPSULE BY
Bhuwan Singla contents : contents 1. Introduction.
4. Shapes Of Capsules.
5. Anatomy Of Soft Gelatin Capsule.
6. The Nature Of Capsule Shell.
7. The Nature Of Capsule Content.
8. Encapsulation Plant Layout Slide 3: 9. Manufacturing Process Of Soft Gelatin Capsule.
10. Product Quality Considerations.
11. In Process Testing.
12. Finished Product Testing.
13. Vegicaps Soft Capsule.
14. Benefits of Vegicaps®Soft capsules Soft gelatin capsule : Soft gelatin capsule DEFINITION:-
soft Gelatin capsules are one piece, hermetically sealed, soft gelatin shells containing a liquid, a suspension, or a semisolid.
The Nomenclature for this dosage form has now
been changed to soft gel .
They have long been preferred dosage form for those, taking Health & Nutritional supplements. ADVANTEGES : ADVANTEGES Easy to administer
Easy to Manufacture
Liquids can be encapsulated ( non water soluble)
Small to large sizes possible
Odour and taste masking
Ready availability of drug hence faster action.
Specialised dosage forms can be made e.g. chewable, extended release, captabs etc.
Can be used for ophthalmic preparations e.g. aplicaps, vaginal / rectal suppositories DISADVANTEGES : DISADVANTEGES Water soluble material are difficult to incorporate
Highly Moisture sensitive
Efflorescent material cannot be incorporated, they may cause softening / leaching
Deliquescent materials cannot be incorporated, they may cause hardening or brittle capsules. Slide 7: Shapes of Capsules - CAPSULE SHELL : CAPSULE SHELL The capsule shell is basically composed of
Gelatin, a plasticizer & water, it may contain additional ingredients such as preservative ,coloring &opacifying agents, flavorings, sugars, acids & medicaments to achieve desired effects.
GELATIN:-Obtain from partial hydrolysis of collagen derived from the skin, connective tissue & Bones of animals. may have viscosity of 38 mpa
cost of gelatin a Bloom strength Capsule shell : Capsule shell WATER:-n.m.t. 45% w/w
The ratio by weight of water to dry gelatin can vary from 0.7 to1.3(water) to 1.0(dry gelatin) depending on the viscosity of the gelatin being used.
PLASTICIZER:-Used to make the soft gel shell elastic & pliable.
Ratio used is between 0.3 to 1.8 for soft to hard shell on dry basis.
E.g. glycerin , sorbitol
. Slide 11: COLOUR used in shell has to be darker than colour of encapsulating material
colours may be natural or synthetic.
OPACIFIER, usually titanium dioxide, may be added to produce an opaque shell ,when the fill formulation is a Suspension or to prevent photo degradation of light sensitive fill ingredients. Conc. Of opacifier may be up to 0.5% Slide 12: Chelating Agents:- Iron is always present in raw gelatin, & should not contain iron more than 15 ppm
Additionally chelating agent may be used for preventing the reaction of iron with materials or colours. Typical formula for gelatin sheet : Typical formula for gelatin sheet Glycerin I.P. 52.0 Kg
PropMethyl Paraben I.P. 0.512Kg
Methyl Paraben I.P. 0.128Kg
Gelatin 120 Bloom I.P. 152.000Kg
Brilliant Blue Ponceau 4R 0.300Kg
Sunset Yellow I.P. 0.300Kg
TiO2 I.P. 16.000Kg
Water I.P. 120.00Ltr
Sorbitol Liq. I.P. 16.00Kg Gelatin Mass Manufacture : Gelatin Mass Manufacture The gel is prepared in a 300-litre stainless steel vessel.
Gelatin powder is mixed with water and glycerine.
The molten gelatin mass is formed.
It is decanted into 200-kg mobile vessels.
where colours and flavours can be added. : It ensures consistency of gelatin mass.
This mass is kept at a constant temperature until it is needed for the next stage of the process. Capsule content : Capsule content Content may be liquid, or a combination of miscible liquids,
A solution of a solid(s) in a liquid(s) or a suspension of a solid(s) in a liquid(s).
It can be a liquid like a volatile oil composition
Vegetable oils like arachis oil or aromatic or aliphatic hydrocarbons, ethers, esters, or alcohols. Slide 17: Solids that are not Sufficiently soluble in liquids or in combination of liquids are capsulated as Suspension.
Suspending agents used are
Lecithin, Soyabean oil, yellow wax. Slide 19: Encapsulation Manufacturing process The gel and fill mobile vessels are then taken to the encapsulation bays.
Where each encapsulation machine is segregated in individual bays.
The molten gel is pumped to the machine.
Two thin ribbons of gel are formed, one either side of the machine. : These ribbons then pass over a series of rollers and over a set of dies that determine the size and shape of the capsules ROTARY DIE ENCAPSULATING MACHINE : ROTARY DIE ENCAPSULATING MACHINE Slide 22: BHUWAN Capsule Manufacturing : Capsule Manufacturing Encapsulation
Tumble Drying :-Dry, sterile air is forced across the tumbler and removes the moisture from the outer surface of the capsules.
Supplemental Drying (curing):- After the tumbler dryers, the soft capsules are placed on special trays for final drying in the drying room. For a period up to 48 hrs. Slide 24: Sizing:- Automatic capsule sizing machine eliminates undersized and oversized capsules.
Inspection:- includes visual inspection to check malformed, damaged or improperly filled capsules.
Packaging:- capsule may be packaged in glass or plastic containers or may be strip-packaged, so long as such packaging involves tight closures & plastics having a low moisture vapor transfer rate. PRODUCT QUALITY CONSIDERATIONS : PRODUCT QUALITY CONSIDERATIONS 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. In-process testing : In-process testing During the encapsulation process the four most important tests are:-
The gel ribbon thickness;
Soft gel seal thickness at the time of encapsulation;
Fill matrix weight & capsule shell weight;
Soft gel shell moisture level and soft gel hardness at the end of the drying stage. Finished product testing : Finished product testing These normally includes
active ingredient assay & related substances assay
Content uniformity and
Microbiological testing. VEGICAPS SOFT CAPSULES : VEGICAPS SOFT CAPSULES Vegicaps®Soft capsules are an alternative animal free capsule. The shell is made from seaweed extract and gluten free starch, and contains no modified sugars or artificial ingredients. The shell can be clear or coloured and there is a wide range of shapes, sizes and colours available. Slide 29: An alternative to gelatin for those who prefer an animal free product
Those with a level of concern about animal-derived products
Those with religious or cultural restrictions
Consumers looking for the most natural alternative. Slide 30: Benefits of Vegicaps®Soft capsules
Free of all animal derivatives – no pork or beef content.
Easy to swallow
Perception of a healthier product
Plant based shell
Low shell odour. Slide 31: THANKS