Genentech, Inc.

James Q Oeswein

Douglas A Yeung

Ross G Clark

Sharon X Wang

Barbara Horsey O'Connor

Xanthe M Lam

Rita L Wong

Boonsri Ongpipattanakul

John R Smikahl

Robert P Weissburg

Zahra Shahrokh

Peter Michel

Michael J Cronin

Zehra Shahrokh

Rodney Pearlman

Robert S Freeman

A composition is disclosed that comprises a mixture of polypeptides of opposite charge and an excipient selected from the group consisting of arginine, lysine, glutamic acid, sodium dodecyl sulfate, beta-hydroxy cyclodextrin, and beta-cyclodextrin sulfobutyl ether.

Formulated composition

A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of antibody not subjected to prior lyophilization, a buffer maintaining the pH in the range from about 4.5 to about 6.0, a surfactant and a polyol is described, along with uses for such a formulation.

Antibody formulation

A stable pharmaceutically acceptable aqueous formulation containing human growth hormone, a buffer, a non-ionic surfactant, and, optionally, a neutral salt, mannitol, or, a preservative, is disclosed. Also disclosed are associated methods for preparing, storing, and using such formulations.

Human growth hormone aqueous formulation

A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody not subjected to prior lyophilization, a buffer maintaining the pH in the range from about 4.5 to about 6.0, a surfactant and a polyol is described, along with uses for such a formulation.

A stable pharmaceutically acceptable aqueous formulation containing human growth hormone, a buffer, a non-ionic surfactant, and, optionally, a neutral salt, mannitol, or, a preservative, is disclosed. Also disclosed are associated means and methods for preparing, storing, and using such formulations.

Formulations containing NPH insulin are useful for treating hyperglycemic disorders, such as diabetes, in a mammal in need of treatment. One such formulation, which is preferably administered parenterally, more preferably by injection, comprises IGF-I and NPH insulin, in amounts of from or about 1 to 10 mg IGF-I and from or about 0.2 to 2 mg NPH insulin in a pharmaceutically acceptable carrier. Another such formulation comprises IGF-I and NPH insulin in an acetic acid salt buffer. Still another formulation comprises IGF-I and NPH insulin in a weight ratio of NPH insulin to IGF-I of from or about 10:1 to 1:50 (w/w), from or about 0.05 to 0.3M of an osmolyte, from or about 0.1 to 10 mg/mL of a stabilizer, and from or about 5 to 100 mM of a buffer at from or about pH 5 to 7. A still further composition comprises NPH insulin in an acetic acid salt buffer.

Formulated insulin-containing composition

A formulation for IGF-I is disclosed that is useful in treating hyperglycemic disorders and, in combination with growth hormone, in enhancing growth of a mammal. Also disclosed is a process for preparing a formulation of growth hormone and IGF-I from the IGF-I formulation. The IGF-I formulation comprises about 2-20 mg/ml of IGF-I, about 2-50 mg/ml of an osmolyte, about 1-15 mg/ml of a stabilizer, and a buffered solution at about pH 5-5.5, optionally with a surfactant.

Formulated IGF-I Composition

Method of formulating IGF-I with growth hormone

An injection pen apparatus (30) for medicament injection including a medicament cartridge assembly (31) formed to receive and contain a medicament therein. A holding sleeve (34) is provided which is dimensioned to receive the medicament cartridge assembly (31) therein which mates with a solution transfer device (35) including an axially movable displacement rod (36). The injection pen apparatus (30) further includes a coupling mechanism (37) removably coupling the solution transfer device (35) to both a plunger (32) slidably movable in the cartridge (33) and to the holding sleeve (34). A sleeve mounting assembly (40) of the coupling mechanism (37) removably mounts the coupling mechanism to the holding sleeve (34). A locking device (41) is included which is formed and dimensioned to require joining of the displacement rod (36) relative the sleeve mounting assembly (40) after uncoupling of the rod from the plunger (32) and before uncoupling of a remainder of the solution transfer device (35) from the holding sleeve (34).

Injection pen solution transfer apparatus and method

A combined formulation for IGF-I and growth hormone (GH) is useful for enhancing growth of a mammal. This formulation, which may be administered by infusion or injection to enhance growth, comprises IGF-I and GH, each in amounts of 0.1 to 100 mg/ml, in a pharmaceutically acceptable carrier at a pH of about 5-6 containing a surfactant, wherein the amounts of IGF-I and GH in the composition are effective to promote growth of a mammal more than an equivalent dose of IGF-I or GH alone, and wherein the weight ratio of IGF-I to GH in the composition ranges from 0.002:1 to 240:1.

Growth-promoting composition and its use

A stable pharmaceutically acceptable formulation containing human growth hormone, glycine, mannitol, a buffer, and optionally, a non-ionic surfactant is disclosed. The formulation contains human growth-hormone: glycine in 1:50-200 molar ratios. Also disclosed are associated means and methods for preparing and using such formulations.

Growing community of inventors

Moss Beach, CA, United States of America

James Q Oeswein