Granular pharmaceutical formulations
AssigneeMay & Baker Limited
InventorTarlok S. Bola
Life of this patent
Estimating the term…
Abstract
A process for the preparation of a granule comprising a pharmaceutical which process comprises contacting a particulate, spray-dried substrate and a particulate pharmaceutical to obtain a particle comprising a substrate core carrying an adsorbed pharmaceutical and contacting the particle with a particulate pharmaceutical and a melted or thermally softened pharmaceutically acceptable excipient which is solid at room temperature to obtain, after cooling to solidify or harden the excipient, a granule comprising a spray-dried substrate core carrying pharmaceutically acceptable excipient and pharmaceutical.
Claims18
A granule comprising:
- a solid, spray-dried adsorbent non-pharmaceutical core carrying an adsorbed first pharmaceutical;
- and
- a coating formed on said adsorbent core, said coating having a stabilizing constituent and a second pharmaceutical constituent, said second pharmaceutical constituent being either the same or different from said adsorbed first pharmaceutical.
A granule consisting essentially of:
- a solid, spray-dried adsorbent non-pharmaceutical core carrying an adsorbed first pharmaceutical constituent present in an amount from 2 to 25% by weight;
- a coating formed on said adsorbent core, said coating having a stabilizing constituent present in an amount of up to 25% by weight and a second pharmaceutical constituent, said second pharmaceutical constituent being either the same or different from said adsorbed first pharmaceutical constituent for:
- a) sustaining release of said adsorbed first pharmaceutical constituent and/or said second pharmaceutical constituent;
- or
- b) pulsing release of said adsorbed first pharmaceutical constituent and/or said second pharmaceutical constituent;
- or
- c) forming an enteric product;
- or
- d) when said adsorbed first pharmaceutical constituent and said second pharmaceutical constituent are different, for administration of drug or drug-excipient mixtures which would otherwise be either physically or chemically incompatible.
A granule comprising:
- a solid spray-dried adsorbent non-pharmaceutical carbohydrate core;
- a first pharmaceutical constituent adsorbed by said carbohydrate core in an amount from 2 to 25% by weight of said granule;
- and
- a coating formed on said carbohydrate core, said coating comprising a pharmaceutically acceptable excipient present in an amount of up to 25% by weight of said granule, and a second pharmaceutical constituent;
- said excipient being a lipid, a wax, a fatty acid, a carboxylate ester, a polyethylene glycol or mixtures thereof;
- said second pharmaceutical constituent being either the same or different from said adsorbed first pharmaceutical constituent.
Dependencies are inferred from the claim text.