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Calf blood deproteinized preparation for preventing or treating diabetic multiple neuropathy

A peripheral neuropathy and deproteinization technology, which is applied in nervous system diseases, medical raw materials derived from mammals, metabolic diseases, etc.

Inactive Publication Date: 2011-11-30
武田奥地利有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The authors concluded that the treatment had no different effect on neuropathic symptoms than placebo (Ziegler D et al., Diabetes Care, Vol 22(8), 1999, 1296-1301)

Method used

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  • Calf blood deproteinized preparation for preventing or treating diabetic multiple neuropathy
  • Calf blood deproteinized preparation for preventing or treating diabetic multiple neuropathy
  • Calf blood deproteinized preparation for preventing or treating diabetic multiple neuropathy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0131] 1) Preparation of solutions for intravenous administration

[0132] A pharmaceutical preparation containing an extract of a deproteinized preparation of calf blood is manufactured by Hormonchemie, Munich under the name " " or marketed under the trademark "Actihaemyl" by Solko, Basel.

[0133] The prior art describes various methods of preparing deproteinized calf blood preparations. German Patent No. 1,076,888 describes the preparation of injectable formulations at a concentration of 30-60 mg dry matter / ml solution by concentrating a solution of said extract. Due to the high thermal instability of the extracts, it is considered that mild drying methods can be used to obtain dry matter and even for the production of solid pharmaceutical forms. Austrian Patent No. 330,953 has disclosed a process for the production of dry formulations from calf blood extracts, wherein said extracts are mixed with an adsorbent such as highly dispersed silica (silica) and the resulting th...

Embodiment 2

[0144] 2) particles

[0145]For the preparation of solid preparations, a fluidized bed method can be employed. Concerning a preferred method of simultaneously obtaining dry matter from an aqueous solution of protein-depleted extract of calf blood and producing granules which can be compressed to give a solid pharmaceutical form containing at least 50% by weight of the extract, and relates to the use of the granules obtained by this method for the production of pharmaceutical preparations containing said protein-depleted extract of calf blood as active substance.

[0146] According to Austrian Patent No. 330,953, another improved alternative for the adsorption of the active substance of the blood extract on a solid material is by freeze-drying (lyophilization) of an approximately 5-10% aqueous solution of the extract to obtain the dry matter. In addition to the fact that freeze-drying relatively large quantities of aqueous solutions consumes a lot of time and energy, the disa...

Embodiment 3

[0191] 3) Manufacturing solid dosage forms using granules

[0192] The resulting granules have a high weight ratio of extracts and exhibit excellent flow properties with a uniform particle size, which allows the granules to be processed into solid drug forms with completely constant weight and high stability. The granules can be used for the production of solid pharmaceutical forms containing deproteinized calf blood extract as active substance. Preferably, compressed products such as tablets, coated tablets, cores or other compressed products of any desired shape and size can be produced. The granules can be compressed directly or after blending with other medically known adjuvants such as tablet binders, fillers, preservatives, tablet disintegrants, etc. The nature and amount of these auxiliaries depend on the desired mechanical strength and dissolution rate of the compressed product.

[0193] Suitable examples of these auxiliaries for blending prior to compression are ste...

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PUM

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Abstract

The present invention relates to a deproteinized calf blood preparation for the prevention or treatment of diabetic polyneuropathy, wherein the deproteinized calf blood preparation is administered parenterally at least once and wherein after parenteral administration Enteral administration for a period of time. Preferably, 20 doses of the deproteinized calf blood formulation are administered intravenously once daily for a period of 20-36 days, followed by oral administration of the deproteinized calf blood formulation for 140 days. In a preferred embodiment of the present invention, the deproteinized calf blood preparation is the agent Actovegin

Description

technical field [0001] The present invention relates to a deproteinized calf blood preparation for preventing or treating diabetic multiple neuropathy, wherein the deproteinized calf blood preparation is administered parenterally at least once and wherein a period of time of enteral administration. [0002] In a preferred embodiment of the present invention, the calf blood deproteinized preparation is a medicament Background technique [0003] Diabetic peripheral polyneuropathy (DPN) is a type of peripheral neuropathy associated with diabetes. Peripheral polyneuropathy (DPN) is the medical term used to define disorders of function and structure of peripheral motor, sensory, and autonomic neurons—including whole neurons or selected levels. Multiple peripheral neuropathy (DPN) primarily affects the feet and legs and causes high morbidity; it occurs in more than one-third of diabetic patients and is associated with fatality related to its severity and complications (such as...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/14A61P3/10A61P25/02
CPCA61K35/14A61P25/02A61P3/10
Inventor L·莫夫西斯扬
Owner 武田奥地利有限公司