Method and compositions for producing granules containing high concentrations of biologically active substances
First Claim
1. A method for preparing granules containing one or more biologically active substances (BAS) comprising mixing a binder with the BAS to obtain a powder mixture, heating the powder mixture to a temperature above the melting point of the binder to obtain an agglomerated powder, wherein the concentration of the binder in the powder mixture is at least that which will agglomerate the powder mixture when the binder is melted and is below that which will result in over-wetting of the powder mixture when the binder is melted, and permitting granules to form from the agglomerated powder.
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Abstract
A method for making granules containing a biologically active substance (BAS) whereby the BAS is mixed with a binder to form a powder mixture having a concentration of binder below that which, when the binder is melted, will cause over-wetting of the powder mixture, heating the mixture to a temperature above the melting point of the binder to form an agglomerated powder, and forming granules from the agglomerated powder. The granules may be used to make pharmaceutical dosage forms such as tablets and capsules.
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Citations
41 Claims
- 1. A method for preparing granules containing one or more biologically active substances (BAS) comprising mixing a binder with the BAS to obtain a powder mixture, heating the powder mixture to a temperature above the melting point of the binder to obtain an agglomerated powder, wherein the concentration of the binder in the powder mixture is at least that which will agglomerate the powder mixture when the binder is melted and is below that which will result in over-wetting of the powder mixture when the binder is melted, and permitting granules to form from the agglomerated powder.
- 18. A method for making tablets containing one or more biologically active substances (BAS) comprising mixing a binder with the BAS to obtain a powder mixture, heating the powder mixture to a temperature above the melting point of the binder to obtain an agglomerated powder, wherein the concentration of the binder in the powder mixture is at least that which will agglomerate the powder mixture when the binder is melted and is below that which will result in over-wetting of the powder mixture when the binder is melted, permitting granules to form from the agglomerated powder, and compressing the granules into tablets.
- 23. A method for making capsules containing one or more biologically active substances (BAS) comprising mixing a binder with the BAS to obtain a powder mixture, heating the powder mixture to a temperature above the melting point of the binder to obtain an agglomerated powder, wherein the concentration of the binder in the powder mixture is at least that which will agglomerate the powder mixture when the binder is melted and is below that which will result in over-wetting of the powder mixture when the binder is melted, permitting granules to form from the agglomerated powder, and encapsulating the granules into capsules.
- 28. A granule comprising one or more biologically active substances (BAS) and a binder, wherein the concentration of BAS in the granule is 80% or higher.
- 35. A tablet comprising one or more biologically active substances (BAS) and a binder, wherein the concentration of BAS in the tablet is 80% or higher.
Specification