Gelatin

Synonyms:Byco; Cryogel; E441; gelatina; gelatine; Instagel; Kolatin; Solugel;Vitagel.

Description: Gelatin occurs as a light-amber to faintly yellow-colored, vitreous, brittle solid. It is practically odorless and tasteless, and is available as translucent sheets, flakes, and granules, or as a coarse powder.

Chemical Name: Gelatin

Coating agent; film-forming agent; gelling agent; suspending agent; tablet binder; viscosity-increasing agent.

• Gelatin is widely used in a variety of pharmaceutical formulations, including its use as a biodegradable matrix material in an implantable delivery system, although it is most frequently used to form either hard or soft gelatin capsules.

• Gelatin capsules are unit-dosage forms designed mainly for oral administration. Soft capsules on the market also include those for rectal and vaginal administration.

• Hard capsules can be filled with solid (powders, granules, pellets, tablets, and mixtures thereof), semisolid and liquid fillings, whereas soft capsules are mainly filled with semisolid or liquid fillings.

• In hard capsules, the active drug is always incorporated into the filling, while in soft capsules the drug substance can also be incorporated into the thick soft capsule shell.

• Gelatin is soluble in warm water (>30C), and a gelatin capsule will initially swell and finally dissolve in gastric fluid to release its contents rapidly.

• Hard capsules are manufactured in two pieces by dipping lubricated stainless steel mold pins into a 45–55C gelatin solution of defined viscosity, which depends on the size of the capsules and whether cap or body are to be formed.

• The gelatin is taken up by the pins as a result of gelation, and the resulting film thickness is governed by the viscosity of the solution.

• The capsule shells are passed through a stream of cool air to aid setting of the gelatin, and afterwards they are slowly dried with large volumes of humidity controlled air heated to a few degrees above ambient temperature and blown directly over the pins.

• The capsule halves are removed from their pins, trimmed and fitted together.

Gelatin is an amphoteric material and will react with both acids and bases. It is also a protein and thus exhibits chemical properties characteristic of such materials; for example, gelatin may be hydrolyzed by most proteolytic systems to yield its amino acid components. Gelatin will also react with aldehydes and aldehydic sugars, anionic and cationic polymers, electrolytes, metal ions, plasticizers, preservatives, strong oxidizers, and surfactants. It is precipitated by alcohols, chloroform, ether, mercury salts, and tannic acid. Gels can be liquefied by bacteria unless preserved

Gelatin is widely used in a variety of pharmaceutical formulations, including oral and parenteral products. In general, when used in oral formulations gelatin may be regarded as a nontoxic and nonirritant material. However, there have been rare reports of gelatin capsules adhering to the esophageal lining, which may cause local irritation.(12) Hypersensitivity reactions, including serious anaphylactoid reactions, have been reported following the use of gelatin in parenteral products

Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection and gloves are recommended. Gelatin should be handled in a well-ventilated environment and kept away from sources of ignition and heat. Empty containers pose a fire risk, and the gelatin residues should be evaporated under a fume hood

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