Use of inhalable powder formulation comprising growth hormone for preventing or treating NMDA receptor hypofunction-related diseases

a technology of nmda receptor and growth hormone, which is applied in the direction of growth hormone, spray delivery, peptide/protein ingredient, etc., can solve the problems of early termination of therapy, compliance of gh application,

Inactive Publication Date: 2012-11-15
MEDIGENEBIO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0014]In accordance with a further aspect of the present invention, there is provided an inhalable powder formulation for preventing or treating an NMDA receptor hypofunction-related disease comprising growth hormone (GH) as an active ingredient.

Problems solved by technology

On the other hand, one of the challenges in GH application is the compliance issue.
While daily subcutaneous injections are needed for maintaining the clinical efficacy of GH, this has not been favored by the patients, especially the pediatric patients, leading to early termination of the therapy (Coste, J. et al., BMJ 315 (7110), 708-713 (1997)).

Method used

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  • Use of inhalable powder formulation comprising growth hormone for preventing or treating NMDA receptor hypofunction-related diseases
  • Use of inhalable powder formulation comprising growth hormone for preventing or treating NMDA receptor hypofunction-related diseases
  • Use of inhalable powder formulation comprising growth hormone for preventing or treating NMDA receptor hypofunction-related diseases

Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of Spray-Dried rhGH Powder

[0062]Human growth hormone (GH; Growtropin, Dong-A Pharmaceutical co., Ltd (Yongin-si, Korea) was first purified by ultrafiltration (MWCO: 10,000) to remove the inactive ingredients included in the solution form of GH. Dry powder containing GH was produced by the LabPlant SD-05 spray dryer (Lab-Plant Plant Ltd, Huddersfield, UK). Dry powder containing bovine serum albumin (BSA; Sigma) instead of GH was also prepared as a negative control.

[0063]In both cases, protein (GH or BSA), lactose (Mallinckrodt (Paris, Ky., USA)), and dipalmitoylphosphatidylcholine (DPPC; Lipoid GmbH (Ludwigshafen, Germany)) were dissolved in the weight ratio of 1:1:3 in 70% ethanol to make a 2 mg / mL feed solution. Briefly, DPPC was first dissolved in 95% ethanol and then combined with an aqueous solution containing GH (or BSA) and lactose. The feed solution was maintained at 40° C. and constantly stirred during the spray-drying process. The solution was introduced to the ...

example 2

Characterization of Spray-Dried rhGH Powder

[0064]To analyze the characteristics of spray-dried rhGH powder prepared in Example 1, three tests were performed.

2-1. Anderson Cascade Impactor (ACI)

[0065]Aerodynamic particle size distribution was determined using an eight-stage Mark II.

[0066]10 mg of the GH Powder obtained in Example 1 samples was manually loaded into hard gelatin capsules (size 3), which were put in a Rotahaler and split-open to release the particles. Glass fiber filters were placed on the ACI stages to prevent particle bounce or re-entrainment (Vanbever, R. et al., Pharmaceutical research V16 (11), 1735 (1999)). Each set of powder was drawn through the induction port into the ACI operated at a flow rate of 28.3 L / min for 10 sec. The amount of particles deposited at individual impaction stage was determined by measuring the difference in weight of glass fiber filters (for the filter stage, pore size <1 μm, ThermoFisher; for all other stages, pore size 1 μm, Pall Corp.) ...

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Abstract

A use of an inhalable powder formulation for preventing or treating an NMDA receptor hypofunction-related disease, a method for preventing or treating an NMDA receptor hypofunction-related disease in a subject, which comprises administering a therapeutically effective amount of an inhalable powder formulation comprising growth hormone (GH) to the subject in need thereof, and an inhalable powder formulation for preventing or treating an NMDA receptor hypofunction-related disease comprising GH as an active ingredient are provided.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a use of inhalable powder formulation comprising growth hormone for preventing or treating NMDA receptors hypofunction-related diseases.BACKGROUND OF THE INVENTION[0002]The indication of growth hormone (GH) replacement has gradually been expanding beyond the original indication for the growth hormone deficiency. The current list of GH replacement includes several genetic disorders characterized by the short stature such as Turner syndrome, Prader-Willi syndrome, and Noonan syndrome. In the Prader-Willi syndrome, GH is expected to be effective in the improvement of the body composition as well as the linear body growth (see, Mogul, H. R. et al., J Clin Endocrinol Metab 93 (4), 1238-1245 (2008)). Based on the efficacy results from the randomized studies, GH was approved by the U.S. Food and Drug Administration for treatment of the idiopathic short stature in children, whose predicted adult height is less than 2.25 SDS (see, ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/27A61P25/32A61P25/28C07K14/61A61P25/18
CPCA61K9/0075A61K9/0073A61K38/27A61P25/18A61P25/28A61P25/32A61K9/14
Inventor LEE, SYPARK, SUNG-LCK
Owner MEDIGENEBIO CORP
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