Compositions and methods for treating precocious puberty
AssigneeEndo Pharmaceuticals Solutions Inc.
InventorPetr KUZMA
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Abstract
The present invention is directed to the controlled delivery of gonadotropin-releasing hormone (GnRH) agonists, preferably from a polymeric material that is implanted in the body. More specifically, the present invention relates to compositions comprised of a GnRH agonist, preferably histrelin, in a polymeric material that results in a desired and controlled delivery of a therapeutically effective amount of GnRH agonist over an extended period of time in order to treat central precocious puberty (CPP).
Claims12
A controlled release reservoir implant containing a formulation comprising (i) histrelin or its pharmaceutically acceptable salt and (ii) stearic acid, the reservoir implant comprising a hydrophilic copolymer obtained from a copolymerization of a mixture comprising about 45% hydroxyethyl methacrylate (HEMA) and about 55% hydroxypropyl methacrylate (HPMA), and which implant provides a therapeutically effective amount of the histrelin or its pharmaceutically acceptable salt in vivo to improve one or more symptoms of central precocious puberty in a patient, wherein the implant provides an average in vivo release rate between 65 micrograms and 70 micrograms of the histrelin or its salt daily in the patient over one year.
A controlled release reservoir implant containing a formulation comprising (i) histrelin or its pharmaceutically acceptable salt and (ii) stearic acid, the reservoir implant comprising a hydrophilic copolymer obtained from a copolymerization of a mixture comprising about 45% hydroxyethyl methacrylate (HEMA), about 54.5% hydroxypropyl methacrylate (HPMA), and about 0.5% trimethylolpropane trimethacrylate (TMPTMA), and which implant provides a therapeutically effective amount of the histrelin or its pharmaceutically acceptable salt in vivo to improve one or more symptoms of central precocious puberty in a patient, wherein the implant provides an average in vivo release rate between 65 micrograms and 70 micrograms of the histrelin or its salt daily in the patient to maintain a mean plasma concentration of histrelin of about 0.2 ng/ml to about 2 ng/ml over one year.
A controlled release reservoir implant containing a formulation comprising (i) 50 mg histrelin acetate and (ii) stearic acid, the reservoir implant comprising a hydrophilic copolymer obtained from a copolymerization of a mixture comprising about 45% HEMA, about 54.5% HPMA and about 0.5% TMPTMA, and which implant provides a therapeutically effective amount of the histrelin acetate in vivo to improve one or more symptoms of central precocious puberty in a patient, wherein the implant provides an average in vitro release rate of between 65 micrograms and 70 micrograms of the histrelin acetate daily over one year.
Dependencies are inferred from the claim text.