Octreotide composition based on subcutaneous gel slow release, preparation method and application

A technology of octreotide and composition, applied in the field of biopharmaceuticals, can solve the problems of inconvenient administration and inability to meet the needs of patients

Pending Publication Date: 2020-06-02
苏州善湾生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The way of administration is very inconven

Method used

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  • Octreotide composition based on subcutaneous gel slow release, preparation method and application
  • Octreotide composition based on subcutaneous gel slow release, preparation method and application

Examples

Experimental program
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Effect test

Embodiment

[0019] Example: Study on release kinetics of octreotide subcutaneous gel formulation in rats

[0020] The main objective of this study was to evaluate the efficacy of three different gel formulations in large 28-day release kinetics in rats. Another goal was to collect blood for plasma concentration analysis of octreotide. The ultimate goal is to evaluate the tissue response of the test site and the tissue compatibility of the test object from a macro perspective.

[0021] In the 28-day study, three subcutaneous gel formulations were tested in 120 male rats. On day 0, four gel formulations (approximately 200 microliters) containing 10 mg of octreotide citrate were injected subcutaneously in the abdomen per rat. On days 1, 7, 14, 21, and 28, rats were anesthetized and bled by cardiac puncture. The plasma concentration of octreotide was analyzed by liquid chromatography / mass spectrometry / mass spectrometry (LC / MS / MS). The subcutaneous residue was removed and subsequently ana...

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Abstract

The invention discloses an octreotide composition based on subcutaneous gel slow release, a preparation method and application. The composition consists of the following ingredients in parts by weight: 20 to 50 parts of thermoplastic polymers, 50 to 70 parts of a biocompatible polar aprotic donor solvent and 2 to 15 parts of octreotide citrate. The octreotide composition prepared by the inventionis slowly degraded along with the slow degradation of a high molecular material after injection, and loaded medicine is slowly released into the body. The medicine release rate in the octreotide composition can be achieved by controlling the molecular weight of polymers and the loading amount of the medicine, so that the requirements of doctors and patients can be met in a targeted manner.

Description

technical field [0001] The invention belongs to the field of biopharmaceuticals, and in particular relates to a sustained-release octreotide composition based on a subcutaneous gel, a preparation method and an application. Background technique [0002] Octreotide is a synthetic octaamino acid peptide. The main indications of octreotide are for the treatment of acromegaly caused by excessive secretion of growth hormone, and for the control of metastatic carcinoid and vasoactive intestinal peptide-secreting tumors. Current clinical use is as a daily subcutaneous injection (Sandostatin, Novartis) or as a one-month sustained-release intramuscular injection (Sandostatin LAR). Sandostatin LAR one month dosage form is a microsphere formulation. Drugs were encapsulated in microsphere polymers prepared from glucose and poly(DL-lactide-glycolide) PLG. The way of administration is very inconvenient and cannot meet the needs of patients. [0003] Therefore, there is an urgent need f...

Claims

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Application Information

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IPC IPC(8): A61K38/08A61K9/06A61K47/34A61P35/04A61P35/00A61P5/00
CPCA61K38/08A61K9/06A61K9/0024A61K47/34A61P35/04A61P35/00A61P5/00
Inventor 齐岩峰
Owner 苏州善湾生物医药科技有限公司
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