Pharmaceutical composition of microspheres for preventing diabetic foot amputation

A technology of microspheres and compositions, which can be used in drug combination, drug delivery, metabolic diseases, etc., and can solve the traumatic problems of patients

Inactive Publication Date: 2014-07-23
CENT DE ING GENETICA & BIOTECNOLOGIA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But this method has an obvious disadvantage: it is very traumatic for the patient since the injection at the lesion is particularly painful
However, none of these methods have proven to be broadly effective

Method used

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  • Pharmaceutical composition of microspheres for preventing diabetic foot amputation
  • Pharmaceutical composition of microspheres for preventing diabetic foot amputation
  • Pharmaceutical composition of microspheres for preventing diabetic foot amputation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1. Preparation of a pharmaceutical composition comprising microspheres of PLGA loaded with EGF

[0036] Preparation of EGF-loaded microspheres

[0037] 1 g of the polymer was dissolved in dichloromethane (DCM) to make a polymer solution (PLGA50:50 (Sigma, St. Louis, Missouri, USA) 10% (w / v)). Add 1 ml of PLGA solution into the glass container, and then add 200 μl of EGF aqueous solution with a concentration of 20 mg / ml. The above-mentioned mixture was ultrasonicated for 30 seconds with an ultrasonic probe (IKASONIC U200S control (IKA Labortechnik, Germany). The first emulsion was added to 40 ml of 1% polyvinyl alcohol, and a T8 Ultraturrax (IKA Labortechnik, Germany) was used to carry out a strong 14000rpm through the opposite phase. Stir to obtain the second emulsion.Add 140ml concentration of double emulsion to 0.1% polyvinyl alcohol 30000-70000 (Sigma, St.Louis, Missouri, USA), and stir 1 hour at 300rpm with homogenizer (IKA Labortechnik, Germany) , to evap...

Embodiment 2

[0060] Example 2. In vivo effects of encapsulated EGF compared to free EGF (in animal models)

[0061] Experimental Model of Controlled Acute Trauma

[0062] The purpose of the trial described here was to evaluate the healing effect of a new pharmaceutical formulation containing EGF microspheres on acute wounds with a satisfactory prognosis, for infiltration at the wound margins and bottom or for parenteral administration by injection.

[0063] test organism model : Male Wistar rats weighing 225-250 g. Animals were housed in a controlled area of ​​CIGB's animal facility under a constant light pattern of 12 x 12 hours, air exchange circulation, and free access to food. Rats were housed individually in T3 boxes and the bedding (pre-sterilized) was changed every 48 hours.

[0064] induced ulcer : Animals were anesthetized by intraperitoneal injection of ketamine / xylazine. The rat's back was depilated mechanically and chemically from the retroscapular space to the sacrum. ...

Embodiment 3

[0123] Example 3. In vivo effect of encapsulated EGF compared to free EGF (in patients with chronic ischemic skin ulcerative wounds)

[0124] A formulation based on EGF microspheres (without excipients) with sustained release properties was administered to patients with diabetic foot ulcers at risk of severe amputation. A 58-year-old female diabetic patient with a right foot of 30.5 cm was treated with the subject formulation of the present invention. 2 chronic ulcers and evidence of ischemia in the affected lower extremity. After wound debridement, in one month, once every 15 days, the preparation of EGF microspheres with slow-release properties was infiltrated on the edge and bottom of the wound. From the first week after starting the treatment, a rapid formation of beneficial granulation tissue was observed, which reached 100% coverage of the affected area by the third week. The patient showed satisfactory development with complete closure of the wound avoiding the need f...

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Abstract

The present invention relates to a pharmaceutical composition that comprises polymeric microspheres containing epidermal growth factor (EGF) for the application, by the parenteral route, into the lower limbs of diabetic patients with cutaneous chronic ischemic ulcerative wounds. The pharmaceutical composition described herein, in contrast with the state of the art, is useful because reduce the administration frequency during the treatment and allows for the healing of the ulcerative wounds in a shorter time interval with respect to the injection of equivalent quantities of non-encapsulated EGF.

Description

[0001] This application is a divisional application of a patent application with application number 200780009034.5, dated January 29, 2007, and titled "Microsphere Pharmaceutical Composition for Preventing Diabetic Foot Amputation". technical field [0002] The present invention relates to a pharmaceutical composition comprising polymeric microspheres containing epidermal growth factor (EGF) for parenteral application in the lower limbs of diabetic patients with chronic ischemic skin ulcerative wounds for prophylaxis Diabetic amputation. Background technique [0003] Diabetes mellitus is a major non-traumatic risk factor for lower extremity amputation. As a major complication of diabetes, the annual incidence of foot ulcers is slightly higher than 2% (Abbott C.A., et al. (2002) The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabet. Med. Vol. 19, No. 5: pp. 377–384). At least 15%...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/18A61K47/34A61K9/16A61P17/02A61P9/14A61P3/10
CPCA61K9/0021A61K9/1647A61K38/1808A61P17/00A61P17/02A61P3/10A61P9/14A61K9/16A61K38/18
Inventor B·Y·贝坦克特罗德里格斯V·M·赛斯马丁内斯R·佩斯梅雷莱斯J·A·贝兰加阿科斯塔J·A·拉蒙埃尔南德斯
Owner CENT DE ING GENETICA & BIOTECNOLOGIA
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