Therapeutic compositions containing methaqualone
AssigneeWilliam H. Rorer, Inc.
InventorsJohn D. Buehler, Pramod B. Chemburkar, Robert S. Joslin
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Abstract
A therapeutic composition of methaqualone and the like quinazolinone compounds or their acid addition salts per se or in combination with other therapeutic agents, said composition containing solubilizing adjuncts and being rapidly and readily absorbed, and methods of making and using same.
Claims9
An orally administrable, rapidly soluble, and readily absorbable, sedative hypnotic composition comprising between 25 mg. to 300 mg. per dosage unit of 2-methyl-3-(o-tolyl)-4(3H)-quinazolinone and its pharmaceutically acceptable acid addition salts, and at least two adjuncts selected from the group consisting of:
- a surfactant effective for wetting and dissolving said quinazolinone present in an amount of 0.5% to 300% by weight of said quinazolinone and selected from the group consisting of a polyoxypropylene-polyoxyethylene nonionic compound, a polyoxyethylene glycol ester of a higher fatty acid, an alkyl phenoxy poly(ethyleneoxy)ethanol, an alkyl poly(ethyleneoxy)ethanol, a complex organic phosphoric acid, a complex organic phosphoric acid ester, a polyoxyethylene derivative of a sorbitan fatty acid ester, and lecithin;
- an acidifier present in an amount between 10% and 1000% by weight of said quinazolinone and selected from the group consisting of hydrochlorides of glycine, glutamic acid and lysine;
- an aggregation preventing carrier present in an amount between 100% and 2000% by weight of said quinazolinone and selected from the group consisting of mannitol, sorbitol, starch, lactose, sucrose, polyethylene glycol of a molecular weight between 1000 and 6000, and microcrystalline cellulose;
- and
- a dispersant present in an amount between 0.5% and 50% by weight of said quinazolinone and selected from the group consisting of finely divided silica and finely divided silicate;
- said quinazolinone compound being present in said composition in the form of finely divided, discrete, substantially non-aggregated particles, wherein the particle size does not exceed 20.mu., at least the majority of said particles being and remaining separate from each other, and the adjuncts being present in intimate contact with the discrete particles of said quinazolinone.
Dependencies are inferred from the claim text.