Enteric coated formulation of bishosphonic acid compounds and associated therapeutic methods
AssigneeLipocine Inc.
InventorsFeng-Jing Chen, Mahesh V. Patel
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Abstract
Oral dosage forms are provided for the administration of a bisphosphonic acid compound in the prevention and treatment of conditions involving calcium or phosphate metabolism, i.e., conditions associated with bone resorption such as osteoporosis, Paget's disease, periprosthetic bone loss, osteolysis, malignant hypercalcemia, metastatic bone disease, multiple myeloma, and periodontal disease. The dosage forms are either enterically coated capsules housing the drug in a liquid or semi-solid carrier, or enterically coated osmotically activated drug delivery devices.
Claims59
A pharmaceutical formulation for oral administration, comprising:
- an enterically coated capsule housing a substantially nonaqueous liquid or semi-solid composition comprised of:
- (a) a therapeutically effective amount of an active agent selected from bisphosphonic acids and pharmacologically acceptable salts, hydrates, and other derivatives thereof;
- and (b) a pharmaceutically acceptable, substantially nonaqueous liquid or semi-solid carrier in which the active agent is dissolved or suspended.
A pharmaceutical formulation for oral administration, comprising:
- an enterically coated capsule housing a liquid or semi-solid composition comprised of:
- (a) a therapeutically effective amount of an active agent selected from bisphosphonic acids and pharmacologically acceptable salts, hydrates, and other derivatives thereof and (b) a pharmaceutically acceptable, liquid or semi-solid carrier in which the active agent is dissolved or suspended, said carrier comprising (i) at least one surfactant selected from polyethylene glycol fatty acid esters, alcohol-oil transesterification products, polyglycerized fatty acids, propylene glycol fatty acid esters, mixtures of propylene glycol fatty acid esters and glycerol fatty acid esters, mono- and diglycerides, sterol and sterol derivatives, sorbitan fatty acid esters and polyethylene glycol sorbitan fatty acid esters, sugar esters, polyethylene glycol alkyl ethers and polyethylene glycol alkyl phenol ethers, polyoxyethylene-polyoxypropylene block copolymers, lower alcohol fatty acid esters, ionic surfactants, and ionizable surfactants, (ii) optionally, at least one triglyceride selected from oils, fractionated triglycerides, modified triglycerides, synthetic triglycerides, and soluble vitamins, and (iii) optionally, at least one organic solvent.
Dependencies are inferred from the claim text.