Dispersible compositions
AssigneeJanssen Pharmaceutica NV
InventorsManish Kumar Gupta, Shripad Wasudeo Marathe, Kaustubh Ramesh Tambwekar, Shreedevi Velayudhan NAIR
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Abstract
The present invention is concerned with dispersible compositions comprising bedaquiline fumarate as an active ingredient. Such compositions are useful in the treatment of tuberculosis and their inherent dispersibility properties lend themselves to be useful in particular amongst the pediatric or geriatric population.
Claims13
A dispersible composition comprising bedaquiline fumarate as the active ingredient and wherein the composition comprises an intra-granular and extra-granular layer in which the intra-granular layer comprises a non-soluble excipient/diluent and is characterised in that the intra-granular layer is absent a soluble excipient/diluent that is starch.
A dispersible composition comprising bedaquiline fumarate as the active ingredient and wherein the composition comprises an intra-granular and extra-granular layer in which the intra-granular layer comprises a non-soluble excipient/diluent that is microcrystalline cellulose.
A dispersible composition comprising by weight based on the total weight of the composition:
- 5 to 50% of bedaquiline fumarate;
- 35% to 90% of a non-soluble excipient/diluent;
- 2% to 10% of a disintegrant;
- 0.1 to 5% of a glidant;
- 0.01 to 5% of a wetting agent or surfactant;
- 0 to 10% of a binder or polymer;
- 0 to 5% of a lubricant;
- and
- solvent (qs).
A dispersible composition comprising by weight based on the total weight of the composition:
- 5 to 50% of active ingredient;
- 20% to 90% of a non-soluble excipient/diluent that is microcrystalline cellulose;
- 2% to 10% of a disintegrant;
- 0.1 to 5% of a glidant;
- 0.01 to 5% of a wetting agent or surfactant;
- 0 to 10% of a binder or polymer;
- 0 to 5% of a lubricant;
- solvent (qs).
A composition, which composition consists of by weight, based on the total weight of the composition:
- 24.18% of active ingredient;
- 62.12% non-soluble excipient/diluent;
- 6% disintegrant;
- 2.5% glidant;
- 0.2% wetting agent or surfactant;
- 3% binder or polymer;
- 2% lubricant;
- Solvent (qs), if necessary.
A composition wherein the different parts of the composition, specifically the intra-granular and extra-granular fraction and binder portion, comprise the following ingredients by weight based on the total weight of the composition:
- Intra-granular fraction
- 5 to 50% of active ingredient;
- 10 to 50% of non-soluble excipient/diluent;
- 1 to 5% disintegrant;
- 0.1 to 5% glidant;
- Binder
- 1 to 10% 3% binder or polymer;
- 0.01 to 5% wetting agent or surfactant;
- Solvent (qs), if necessary
- Extra-granular fraction
- 10 to 50% of excipient/diluent;
- 1 to 5% disintegrant;
- 0 to 3% glidant;
- 0 to 5% lubricant.
13-18. (canceled)
Dependencies are inferred from the claim text.