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A slow-release drug delivery system

A pharmaceutical and pharmaceutical technology, applied in the field of sustained-release drug delivery system composition and its preparation, can solve the problems of pain and irritation at the injection site, oil-gel preparations that have not been seen, preparation application limitations, etc., and achieve good biocompatibility sex, good drug safety and tolerability, and ease of administration

Active Publication Date: 2022-07-22
NANJING DELOVA BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the oil gel also has the following problems. First, the oil gel is a semi-solid preparation with high viscosity and difficult injection, which is not conducive to clinical administration. Secondly, most of the gel factors may have safety problems and have not been used for injection. Oleogel formulation
[0008] Moreover, the currently used formulations containing non-aqueous solvents are also prone to pain and irritation at the injection site, which limits the application of such formulations

Method used

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  • A slow-release drug delivery system
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0102] The dissolving situation investigation of embodiment 1 different types of saturated phospholipids in castor oil and each organic solvent

[0103]Take 1g of castor oil and organic solvent respectively in EP tube, add 0.1g of saturated phospholipid (about 100mg / g, 10%w / w), ultrasonic at 50℃, observe the dissolution, the results are shown in Table 1-1.

[0104] Table 1-1 Dissolution investigation

[0105]

[0106] Wherein, EtOH stands for absolute ethanol; BB stands for benzyl benzoate; BA stands for benzyl alcohol; NMP stands for N-methylpyrrolidone; DMSO stands for dimethyl sulfoxide.

[0107] According to the solubility investigation, saturated phospholipids (HSPC, DPPC, DMPC, DSPC) have good solubility in alcohol solvents (ethanol, benzyl alcohol, propylene glycol, etc.), while phosphatidylglycerol (DPPG), phosphatidylethanolamine (DPPE) , phosphatidic acid (DPPA) can not be dissolved in the above solvents.

Embodiment 2

[0108] Embodiment 2 Composition ratio research

[0109] (1) Form test of composition at room temperature

[0110] The compositions were prepared according to each ingredient and ingredient ratio shown in Table 2-1 below. The solvent phospholipid, oil and solvent were mixed, heated and stirred until a transparent and homogeneous solution was formed, cooled to room temperature, and the physical form was investigated. At the same time, the room temperature form of the unsaturated phospholipid composition was used as a comparative study.

[0111] Table 2-1 Room temperature form of compositions under different ratios

[0112]

[0113] In this example, the formulations of compositions containing 0.5-30% (w / w) saturated phospholipids (HSPC, DPPC, DSPC and DMPC) and 0-50% (w / w) solvent at room temperature were investigated, and the results are shown in Table 2 As shown in -1, the room temperature form of the composition of the present invention is related to the amount of satura...

Embodiment 3

[0122] (1) Effects of different types of phospholipids on the phase transition of the composition

[0123] Pharmaceutical compositions containing saturated phospholipids (composition 16), without phospholipids (pure castor oil group) and containing unsaturated phospholipids were prepared according to Table 3-1. Meloxicam was dissolved in N-methylpyrrolidone to prepare a concentrated solution of 50 mg / g, ropivacaine, soy lecithin or dipalmitoyl phosphatidylcholine were added to liquid oil, solvent and meloxicam at 50°C Kang solution, heating and stirring until a transparent and homogeneous solution was formed, and cooled to room temperature. The composition was slowly injected into water with a syringe, and the morphological changes of different compositions in water were observed. see the results Picture 1-1 .

[0124] Table 3-1 Different compositions

[0125]

[0126] The above experiments respectively investigated the morphological changes in water containing saturate...

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Abstract

The present invention relates to a pharmaceutical composition, comprising liquid oil, at least one compound represented by the following formula I, and at least one pharmaceutically active ingredient. The pharmaceutical composition can be used in a sustained-release formulation system, so that the drug is in a semi-solid or solution form at room temperature, the semi-solid formulation can be directly used as a drug reservoir at the administration site, and the liquid formulation is in contact with the body fluid at the administration site. A phase transition occurs to form a drug depot, while improving drug safety and tolerability.

Description

technical field [0001] The invention belongs to the field of sustained-release pharmaceutical preparations, in particular to a sustained-release drug delivery system composition and a preparation method thereof. Background technique [0002] Injectable sustained-release preparations are one of the current research hotspots of pharmaceutical preparations, which aim to provide a drug reservoir that can be used for subcutaneous injection, intramuscular injection, intramuscular injection, local injection and other administration methods. Among them, local injection refers to local administration, such as injection in the spinal cavity, joint cavity, wound, eye, etc., and the drug can be administered locally after being slowly released. [0003] Injectable sustained-release preparations have many advantages, such as: the preparation can be directly injected into the desired administration site and slowly release the drug, reducing systemic toxicity and increasing the therapeutic ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K45/00A61K47/14A61K47/24A61K47/28A61K47/44
CPCA61K9/06A61K45/00A61K47/24A61K47/44A61K47/14A61K47/28A61K9/00A61K9/08
Inventor 王青松武曲邹丽敏
Owner NANJING DELOVA BIOTECH CO LTD
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