Dr. Reddy's Laboratories, Incorporated

Nostrum Pharmaceuticals, Inc.

Dr. Reddy's Laboratories New York, Inc.

Apr LLC

John S Lomans

Carmen Leiva-paredes

Prashant Anil Tatake

Chandrashaker Akula

Madhukiran Tummidi

A method of obtaining conjugated estrogens from pregnant mare's urine by supercritical fluid extraction and the product thus obtained is disclosed.

Isolation and purification of conjugated estrogens

The present application relates to a method for obtaining a mixture of estrogens from the pregnant mare's urine.

Process for purification and isolation of estrogens

A process in which urine is optionally filtered to remove solid extraneous matter and optionally treated so as to reduce the phenolic content of the urine to give and the resulting fluid is then subjected to a solid extraction of the major concentration steroids content therefrom by a first suitable resin (to yield a first resin laden with major concentration steroids and a minor concentration steroid laden first liquid remainder). The minor concentration steroid liquid remainder is subjected to a solid extraction of the minor concentration steroid content therefrom by a second suitable resin (to yield a second resin laden with minor concentration steroids and a second liquid remainder). The first and second resins laden with their respective steroids are then eluted and the eluates are collected separately and optionally subjected to further purification and chromatographic separations, with each resulting separate collection being analyzed for the steroid content thereof. The separate analyzed materials are dried and stored for recombination in an appropriate manner to meet a desired profile. The ultimate product has very nearly the same steroid components and concentrations from batch to batch.

Steroid extraction process from urine sources

The present invention relates to a process for extracting conjugated estrogens from pregnant mare urine. The present invention further relates to a process for obtaining a natural mixture of conjugated estrogens. The mixture of conjugated estrogens can be used to prepare products for estrogen replacement therapy or hormone replacement therapy. More specifically, the process for extracting conjugated estrogens from PMU comprises the steps of (a) contacting a mare urine material (MUM) with a resin to adsorb phenolic components, (b) contacting the phenolics-depleted MUM of step (a) with a resin to adsorb the stone and equilin, the major estrogen components, (c) containing the major estrogen-depleted MUM of step (b) with a resin to adsorb the minor estrogen components, (d) separately desorbing the major estrogen components and the minor estrogen components from the resins used in steps (b) and (c), and (e) separately treating the desorbed material form step (d) to obtain crystals of the major estrogen components and the minor estrogen components.

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Middleburgh, NY, United States of America

John S Lomans