Liquid dosage forms of isotretinoin
AssigneeRanbaxy Laboratories Limited
InventorsSanjay Kumar Motwani, Shashikanth P. Isloor, Vinod Arora
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Abstract
The present invention relates to a pharmaceutical solution comprising isotretinoin or salts thereof. The present invention further relates to the processes for preparing such compositions.
Claims17
A pharmaceutical solution comprising isotretinoin or pharmaceutically acceptable salts thereof and a pharmaceutically acceptable carrier.
A process of preparing a pharmaceutical solution of isotretinoin comprising the steps of:
- (i) dissolving isotretinoin in a carrier by continuous stirring at room temperature, or at higher temperatures, till a homogenous solution is formed;
- and
- (ii) cooling the solution of step (i) to room temperature, optionally, adding one or more excipients.
A process of preparing a pharmaceutical solution of isotretinoin comprising the steps of:
- (i) dissolving one or more excipients in a carrier by continuous stirring;
- (ii) dissolving isotretinoin in the solution of step (i) by continuous stirring at room temperature, or at higher temperatures, till a homogenous solution is formed;
- and
- (iii) cooling the solution of step (ii) to room temperature.
A process of preparing a pharmaceutical solution of isotretinoin comprising the steps of:
- (i) dissolving one or more excipients in a carrier by continuous stirring;
- (ii) suspending the isotretinoin in the solution of step (i) under continuous stiffing and milling the suspension to form a homogenous micronized suspension;
- (iii) diluting the suspension of step (ii) with a carrier to the desired concentration
- (iv) diluting the suspension of step (iii) with a suitable carrier to form a clear solution of isotretinoin at the time of administration.
A method of treating acne, musculoskeletal and connective tissue inflammations, emphysema, ulcerating diseases, cervical tumors in HIV positive women, lung cancer in smokers, skin cancer, neuroblastoma, recurrent prostrate cancer, leukemia, high-grade glioma, head and neck cancers, multiple myeloma, gram-negative folliculitis, recalcitrant rosacea, pyoderma faciale, generalized lichen planus, psoriasis, cutaneous lupus erythematosus and acne fulminans, squamous cell carcinoma, cutaneous photoaging and other off-label indications of isotretinoin, by administering a pharmaceutical solution comprising isotretinoin or pharmaceutically acceptable salts thereof and a pharmaceutically acceptable carrier.
Dependencies are inferred from the claim text.