Oral solid dosage forms, methods of making same and compositions thereof
AssigneeQuadrant Holdings Cambridge Limited
InventorsBruce J. Roser, Julian Blair, Camilo Colaco, Ross Henry Morris Hatley
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Abstract
Methods of making tablets of a variety of physical forms are described. The tablets can be made into a wide variety of formulations. The invention further provides methods of making crystalline and amorphous anhydrous trehalose for use in formulating tablets suitable for use in dispensing pharmaceutical agents.
Claims31
A method of making tablets comprising the steps of:
- (a) combining components comprising an amount of anhydrous trehalose sufficient to act as an effective diluent in the tablets formed and an amount of an active agent such that each tablet formed contains an effective amount of active agent and an amount of aqueous solvent sufficient to suspend or dissolve the anhydrous trehalose and active agent;
- (b) processing the product of step (a) to form a powder comprising a substantially homogeneous mixture of the components, wherein the powder is formed using a process other than spray freeze drying;
- and
- (c) forming tablets from the powder.
A method of making tablets comprising the steps of:
- (a) combining, in substantially dry form, components comprising an amount of anhydrous trehalose sufficient to act as an effective diluent in the tablets formed and an amount of an active agent such that each tablet formed contains an effective amount of active agent;
- (b) processing the product of step (a) to form a substantially homogeneous mixture;
- and
- (c) forming tablets from the powder of step (b).
A method of producing anhydrous trehalose comprising the steps of heating trehalose dihydrate at a temperature, for a duration of time and under conditions sufficient to reduce the water content to about 0 to 2%.
Dependencies are inferred from the claim text.