Microcrystalline tableting excipient derived from whey

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills

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524 56, 426583, 427 3, A61K 700, A61K 716, A23C 2100, A23C 2102

Patent

active

046702512

ABSTRACT:
A solid pharmaceutical composition suitable for oral or rectal administration comprising a unit dosage of a pharmaceutically active ingredient (and optionally one or more inert fillers) homogeneously dispersed in a pharmaceutically acceptable binder, wherein at least a major portion (i.e., at least 50% by weight) of the binder is a microcrystalline solid phase prepared by raising the pH of a dairy whey lactose permeate having a pH below about 7 to a pH between about 8 and 10 to form (i) a lactose-rich aqueous solute phase capable of being autoclaved for 10-20 minutes at 121.degree. C. and 15 psi to form a clear, light-colored solute having a pH of about 7; and (ii) a microcrystalline solid phase which contains substantially all of the dissolved solids from said solute phase which would form a precipitate upon autoclaving said solid phase; separating the microcrystalline solid phase from the solute phase; and drying the separated microcrystalline solid phase to form a nontoxic, tasteless, odorless, chalky white free-flowing powder.

REFERENCES:
patent: 3922339 (1975-11-01), Shear
patent: 4036999 (1977-07-01), Grindstaff
Pernarowski, M., PhD, "Solutions, Emulsions and Suspensions", Chapter 83, Remington's Pharmaceutical Sciences (15th Edition, 1975, pp. 1436-1460).
Baichwal, A. R. and Shangraw, Ralph F., "Tableting Properties of a New Protein/Lactose/Mineral Complex", Pharmaceutical Technology, (Sep. 1985).

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