Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Patent
1996-07-31
1998-05-19
Levy, Neil S.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
424442, 424484, 424485, 424488, 574561, A61K 914
Patent
active
057532540
DESCRIPTION:
BRIEF SUMMARY
This invention relates to novel pharmaceutical compositions comprising one or more thyroid hormones, and to their use in the treatment of disorders associated with impairment of the thyroid hormone functions in animals including human beings.
Pharmaceutical compositions comprising solid fast dispersing dosage forms for oral administration have recently become available. The dosage forms are prepared by freeze drying, a relatively slow process, which involves the use of expensive and complicated equipment. Furthermore, fast dispersing dosage forms produced by freeze drying are very friable and extremely moisture sensitive, which makes them difficult to package. For example, when presented in a conventional blister pack they are not sufficiently hard to retain their integrity when a force is applied to break the package seal and eject them from the blister. Such tablets are also unsuitable for conventional packing into bottles. Known freeze dried fast dispersing dosage forms have the further disadvantage that they are difficult to prepare other than as large tablets.
Therefore it is an object of the invention to provide a solid fast dispersing oral dosage form for a pharmaceutical composition as described herein which avoids all or some of the disadvantages of known freeze dried rapidly dispersing dosage forms whilst retaining all or some of the advantages of fast dispersing dosage forms over more conventional solid oral dosage forms.
These advantages include good patient compliance as fast dispersing dosage forms are easy to ingest as they disintegrate readily and quickly in the mouth within seconds imparting a pleasant sensation to the mouth. This can be particularly useful for patients such as children or the elderly who have difficulty in swallowing, as no extra liquid (eg water) is required to take these oral dosage forms. Fast dispersing oral dosage forms have the further advantage that the thyroid hormone active ingredient is presented to the gastro-intestinal tract in a finely divided particulate form which favours optimal and consistent absorption into the body.
To improve convenience and patient compliance the oral dosage forms of the present invention may be made of a mass typically ten times smaller than possible for freeze-dried dosage forms. Small oral dosage forms have the further advantage of minimising the amount of diluents ingested particularly when the therapeutic agent is present in very small amounts, for example the microgram quantities per unit dose required if the therapeutic agent is thyroid hormone.
Thyroid hormones as described are useful in the treatment of disorders associated with improvement of the thyroid hormone function in animals including human beings for example myxedema, cretinism or obesity. Thyroid hormones can be prepared synthetically as the biologically active 1-enantiomer or can be isolated direct from the thyroid gland of animals.
Therefore the present invention provides a solid fast dispersing dosage form of a pharmaceutical composition suitable for oral administration comprising: a therapeutic agent which comprises at least one thyroid hormone; from about 80% to about 99.9% of disintegrating agent; from about 0.01% to about 10% of flavouring agent; and from about 0.1% to about 5% of lubricating agent, all percentages being percentage mass of ingredient by total mass of the composition (known hereinafter as `by mass`).
Surprisingly, the present invention provides pharmaceutical compositions giving the above stated advantages of fast dispersing oral dosage forms without freeze drying. Freeze drying is a time consuming and expensive process requiring significant capital investment in specialised plant and machinery and high maintenance and operating costs. The production of the solid fast dispersing oral dosage form of the present invention by using simple formulation and processing technology results in major cost savings over production of known rapidly dispersing oral dosage forms. The lubricating agent is added to the composition to aid compression of the soli
REFERENCES:
patent: 3090724 (1963-05-01), Bowen
patent: 5464632 (1995-11-01), Cousin et al.
Khan Karrar Ahmad
Smith Alan
Knoll Aktiengesellschaft
Levy Neil S.
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