Soft Gelatin Capsules PDF

 Soft gelatin capsules Introduction Soft gelatin capsules consist of one piece hermetically-sealed soft shells. The softgel capsule shell consists of gelatin, water and a plasticizer. plasticizer, such as glycerin or polyhydric alcohol (e.g., sorbitol). The plasticizer makes g...

 Soft gelatin capsules Introduction Soft gelatin capsules consist of one piece hermetically-sealed soft shells. The softgel capsule shell consists of gelatin, water and a plasticizer. plasticizer, such as glycerin or polyhydric alcohol (e.g., sorbitol). The plasticizer makes gelatin elastic. Soft gelatin capsules, which contain more moisture than hard capsules, may have a preservative, such as methylparaben and/or propylparaben, to prevent microbial growth. The softgel can be coated with enteric-resistant or delayed release material. It may be transparent or dark, and can be coloured and flavoured if desired. Soft gelatin capsules are used to encapsulate and hermetically seal liquids, suspensions, pasty materials, dry powders, and even preformed tablets. Soft gelatin capsules come in various shapes with and without twist off. Soft gelatin capsules may be oblong, oval, or round. They are formulated such that to : 1. smallest possible capsule, consistent with maximum amount of ingredient and it is physically stable. 2. therapeutically effective 3. production efficiency. The name for this dosage form has now been changed to soft gel (also called soft elastic)  Description of the soft gelatin capsule dosage form (SOFTGELS) Softgels consist of a liquid or semisolid matrix inside a one-piece outer gelatin shell. Ingredients that are solid at room temperature can also be encapsulated into softgels, they are at least semisolid below approximately 45°C. The drug compound itself may be either in solution or in suspension in the capsule-fill matrix. The characteristics of the fill matrix may be: - hydrophilic (for example polyethylene glycols) or - lipophilic (such as triglyceride vegetable oils). - the matrix may be a mixture of both hydrophilic and lipophilic ingredients. Significant advances have been made in recent years in the formulation of softgel fill. These include microemulsions and nanoemulsions encapsulated as preconcentrates in softgels. The term 'preconcentrate' means that the softgel fill matrix is a combination of lipophilic and hydrophilic liquids as well as surfactant components, which after oral administration disperse to form, for example, a microemulsion. If the dispersion results in even smaller droplets in the nanoparticle range, then the dispersion is known as a nanoemulsion.  Softgels can be formulated and manufactured to produce a number of different drug delivery systems: 1. Orally administered softgels containing solutions or suspensions that release their contents in the stomach in an easy to swallow, This is the most common type of softgel. 2. Chewable softgels where a highly flavoured shell is chewed to release the drug liquid fill matrix. The drug(s) may be present in both the shell and the fill matrix. 3. Suckable softgels which consist of a gelatin shell containing the flavoured medicament to be sucked and a liquid matrix or just air inside the capsule. 4.Twist-off softgels, which are designed with a tag to be twisted or snipped off, allowing access to the fill material. This type of softgel can be very useful for unit dosing of topical medication, inhalations, or oral dosing of a paediatric product. 5. Meltable softgels designed for use as 'patient friendly‘ like suppositories.  Advantages of soft gelatin capsules 1. Easy to swallow, tasteless, available in different variety of shapes, colours, and sizes. 2. Accuracy and uniformity of dosage 3. Easy to Manufacture 4. Small to large sizes possible 5. Portability 6. Odor and taste masking 7. Specialized dosage forms can be made e.g. chewable, extended release. 8. Good product stability (drugs protected against oxidative degradation by lipid vehicles and gelatin shells) 9. liquid medications to become easily encapsulated and increases the bioavailability. 10.Low melting point drugs can also be easily incorporated. 11.Safer handling of highly potent or cytotoxic drug compounds. 12.Dissolution rate or disintegration time are better, so they show an advantage over other solid dosage formulations  Disadvantages of soft gelatin capsules 1. Water soluble material are difficult to incorporate 2. Highly Moisture sensitive 3. Efflorescent material cannot be incorporated, they may cause softening / leaching 4. Deliquescent materials cannot be incorporated, they may cause hardening or brittle capsules. 5. Liquids that can easily migrate through the capsule shell are not suitable for soft gelatin capsules. These materials include water above 5% and low–molecular-weight water-soluble and volatile organic compounds such as alcohols, ketones, acids, amines, and esters. 6. Need special type of equipments for the manufacture Applications of Soft Gelatin Shell Capsules As an oral dosage form for human or animal use. As a suppository dosage form for rectal or vaginal use. package in the tube shape, for human or animal use of topical, ophthalmic, (ear) preparations. In the cosmetic industry, these can be formulated as a speciality package for breath fresheners, perfumes, bath oils, skin creams etc. Size and Shapes of soft gelatin capsules  Capsule shell contents 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. gel strength 150-250 gm Capsule shell WATER 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 &. Ratio used is between 0.3 to 1.8 for soft to hard shell on dry basis. E.g. glycerin, sorbitol. 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 shell, when the fill formulation is a suspension or to prevent photo degradation of light sensitive ingredients. Concentration of opacifier may be up to 0.5% Chelating Agents Iron is always present in raw gelatin, & should not contain iron more than 15 %. Additionally chelating agent may be used for preventing the reaction of iron with materials or colours. Vehicles used with Soft gelatin capsules are : Water miscible liquids: 1. PEG-400, polysorbates (non-ionic surfactants). 2. 5-10 % propyline glycol, ethanol, gleycerin. Water immiscible liquids: 1. A. vegetable oils, esters, ethers. 2. B. aliphatic and aromatic chlorinated hydrocarbons. Gelatin Mass Manufacture The gel is prepared in a 300-litre stainless steel vessel. Gelatin powder is mixed with water and glycerine. Heating. Stirring. The molten gelatin mass is formed. It is decanted into 200-kg mobile vessels. mixing 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