Pharmagel Engineering

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Pharmagel Engineering
Softgel Technologies PDF  | Print |

Soft gelatine capsules are one-piece and hermetically sealed to enclose a liquid or semi liquid fill, in contrast with hard gelatine capsules  which are two-pieces shells filled with a powder. Soft gelatine capsules are manufactured - formed, filled and sealed - in one operation, instead of two, typical of hard capsules. In the soft gelatine encapsulation process two sheets, called ribbons, are formed from molten gelatine mass, and each sheet is passed over a die of the desired capsule size and shape. Exactly where the two rotating dies meet, the capsule is formed and filled with a liquid that contains the active ingredients in an excipient vehicle.

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Soft Gelatine Capsules - Softgels - while being highly specialised and needing not freely available technology, have shown a considerable growth in the past decade.  This is due to their bioavailability & marketing advantages.
Softgels consist of a liquid or a paste material inside a one-piece outer gelatine and glycerine envelope, in which the medicine, vitamin, mineral, herb or cosmetic may be in solution or in suspension in the surrounding fill material. For some special products, self-emulsifying or micro emulsion vehicle systems are developed.  Softgels deliver drugs in a liquid form via a solid dosage form – hence the bioavailability & marketing advantages.
There are a great number of reasons and advantages why Softgels may be selected.
Rapid action due to their short disintegration time.  This valuable softgel advantage may be used to improve the bio availability of some medicines. The general bioavailability of different dosage forms follows the descending order emulsion, Softgels, aqueous suspensions, hard shell capsules and tablets.
One of a further aspect of improved compliance is that if a drug solution in a softgel delivery system enhances its bioavailability, it may be possible to reduce the dose that needs to be administrated to achieve therapeutic effectiveness – often saving cost and reducing side effects.

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In addition, medicines which easily degrade in the presence of oxygen are protected from degradation and shelf life is extended – herbs and vitamins are good examples of products that benefit.
Accuracy. Softgels are made by an efficient and continuous process in which they are filled and sealed simultaneously rather than having to be filled as a separate operation in a batch process. It is possible to seal liquids, semi-liquids, solutions, suspensions and gels with an overall accuracy of + 1.0% - 2.5% inside the capsule shell, depending on the fill substance.
Since the active substances are dissolved or suspended in liquids, homogeneous mixtures are obtained, which is especially valuable for the manufacture of dosage forms containing small amounts of drugs .
Softgels can be used internally, as chewable, applied externally, or used for ophthalmic preparations, suppositories and vaginal pessaries. Since a wide variety of sizes is available, unit dosages can also be readily designed for animal health care.

 

 

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