Liquid formulation of follicle stimulating hormone

A follicle-stimulating hormone and preparation technology, which is applied in the directions of medical preparations without active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas

Inactive Publication Date: 2012-12-12
INTAS BIOFARMASJUTIKALS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, lyophilized products are inconvenient in that they must be reconstituted by dissolving them in water for injection (WFI) before using them

Method used

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  • Liquid formulation of follicle stimulating hormone
  • Liquid formulation of follicle stimulating hormone
  • Liquid formulation of follicle stimulating hormone

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0071] Production of Recombinant Human FSH by Recombinant DNA Technology

[0072] Recombinant human FSH is produced in transfected CHO host cells by standard methods.

example 2

[0074] Preparation of hFSH aqueous formulations using trehalose and mannitol

[0075] Phosphate buffer at pH 7.0 was prepared using a formulation buffer comprising monobasic sodium phosphate monohydrate and disodium hydrogen phosphate dehydrate. Mannitol, trehalose and sodium chloride were added to the phosphate buffer as stress regulators and stabilizers. L-methionine as an antioxidant and polysorbate 20 as a stabilizer were added to the solution to form a formulation buffer, pH was adjusted with phosphoric acid solution or sodium hydroxide solution to obtain a pH of 7.0 ± 0.2 . The volume was brought to 100% with WFI and the solution was stirred well. The required amount of formulation buffer is mixed with phenol to form a homogeneous mixture. The calculated amount of rHu FSH drug substance was added with continuous stirring until a homogeneous mixture was fully formed.

[0076] Table 1: Formulations of hFSH

[0077] serial number

example 3

[0078] Example 3: Stability testing of hFSH aqueous formulations

[0079] Biological tests were carried out in compliance with European Pharmacopoeia specifications.

[0080] Check protein concentration by SE-HPLC

[0081] The formulation of Example 1 was evaluated for protein content of FSH using size exclusion HPLC.

[0082] Protein content was measured at time zero and after storage of the formulations at 5±3°C, 25±2°C for 1, 2, 3 and 6 months. The results are listed in Table 1 as micrograms of FSH per gram of solvent.

[0083] Reverse Phase HPLC Oxidation Analysis

[0084] The protein content of FSH was assessed on the aqueous formulation of Example 1 using a reverse phase HPLC method.

[0085] Purity was measured at time zero and after storage of the formulations at 5±3°C, 25±2°C for 1, 2, 3 and 6 months. The results are listed in Table 2.

[0086] dissociate

[0087] For the formulations given in Table 1, the percentage of free subunits was assessed by SDS-PAGE. ...

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Abstract

The present invention relates to an aqueous formulation of a follicle stimulating hormone (hFSH) which is stabilized to maintain the activity of hFSH for a prolonged period of time.

Description

[0001] related application [0002] This application is related to Indian provisional application 384 / MUM / 2010 filed 12 February 2010, the contents of which are hereby incorporated by reference. technical field [0003] The present invention relates to a novel aqueous formulation of human follicle stimulating hormone (FSH) that is stable at ambient or body temperature for extended periods of time to ensure a reasonable shelf life. More specifically, it relates to an aqueous formulation of human follicle stimulating hormone comprising a therapeutically effective amount of human FSH stabilized in a buffer comprising one or more stabilizers, a A nonionic surfactant, an antioxidant, an inorganic salt, and one or more preservatives. Background technique [0004] Human follicle-stimulating hormone (FSH) is a hormone that plays an important role in reproductive function under the synergy of luteinizing hormone (LH) and human chorionic gonadotropin (hCG). Structurally, FSH is a he...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/24
CPCA61K9/0019A61K47/02A61K38/24A61K47/26A61K47/183A61K47/20
Inventor 苏迪普·库马尔·玛杰姆德马尼施·库马尔·夏尔马塔伦·库马尔·古浦塔
Owner INTAS BIOFARMASJUTIKALS
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