.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for Patent: 5,652,365

« Back to Dashboard

Details for Patent: 5,652,365

Title: Process for the production of finasteride
Abstract:A process for producing polymorphic Form I of finasteride, 17B-(N-tert-butyl carbamoyl)-4-aza-5.alpha.-androst-1-en-3-one, in substantially pure form comprising the steps of: (1) crystallization from a solution of finasteride in a water immiscible organic solvent and 0% or more by weight of water, producing solvated and non-solvated finasteride in solution, such that the amount of organic solvent and water in the solution is sufficient to cause the solubility of the non-solvated form of finasteride to be exceeded and the non-solvated form of finasteride to be less soluble than any other form of finasteride in the organic solvent and water solution: (2) recovering the resultant solid phase; and (3) removing the solvent therefrom; wherein the water immiscible organic solvent is ethyl acetate or isopropyl acetate and the amount of water in the solvent mixture is below 4 mg./ml.
Inventor(s): McCauley; James A. (Belle Meade, NJ), Varsolona; Richard J. (Scotch Plains, NJ)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Filing Date:Mar 30, 1995
Application Number:08/411,685
Claims:1. A process for producing polymorphic Form I of 17.beta.-(N-tert-butyl carbamoyl)-4-aza-5.alpha.-androst-1-3-one in substantially pure form, comprising the steps of:

(1) crystallization from a solution of finasteride in a water immiscible organic solvent and 0% or more by weight of water, producing solvated and non-solvated finasteride in solution, such that the amount of organic solvent and water in the solution is sufficient to cause the solubility of the non-solvated form of finasteride to be exceeded and the non-solvated form of finasteride to be less soluble than any other form of finasteride in the organic solvent and water solution;

(2) recovering the resultant solid phase; and

(3) removing the solvent therefrom;

wherein the water immiscible organic solvent is ethyl acetate and the amount of water in the solvent mixture is at most about 3.5 mg/ml.

2. A process for producing polymorphic Form I of 17.beta.-(N-tert-butyl carbamoyl)-4-aza-5.alpha.-androst-1-en-3-one in substantially pure form, comprising the steps of:

(1) crystallization from a solution of finasteride in a water immiscible organic solvent and 0% or more by weight of water, producing solvated and non-solvated finasteride in solution, such that the amount of organic solvent and water in the solution is sufficient to cause the solubility of the non-solvated form of finasteride to be exceeded and the non-solvated form of finasteride to be less soluble than any other form of finasteride in the organic solvent and water solution;

(2) recovering the resultant solid phase; and

(3) removing the solvent therefrom,

wherein the water immiscible organic solvent is iso-propyl acetate, and the amount of water in the solvent mixture is at most about 1.6 mg/ml.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc