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In-situ gel injection implant

A technology for injecting implants and in-situ gels, which is applied in the field of in-situ gel injection implants, can solve the problems of increased side effects, inconvenience, and repeated disease, and achieve the effect of simple preparation and convenient use

Active Publication Date: 2013-12-18
LIAONING RES INST OF FAMILY PLANNING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For this class of drugs, there are many problems to be solved when the conventional drug delivery system is adopted: the patient needs to take the drug frequently or receive injections, and the interruption of the drug will cause the recurrence of the disease and bring great inconvenience to the patient; Due to the influence of "first-pass effect" and other effects, the bioavailability of drugs is low and individual differences are large; stable blood drug concentrations cannot be maintained for a long time, which reduces the therapeutic effect of drugs and increases side effects; for some peptides and genetic drugs, due to small intestinal Absorption resistance, conventional oral preparations cannot achieve drug delivery
However, existing implants require a surgical incision under local anesthesia and a similar procedure for removal if the implant is non-biodegradable
This brings great inconvenience to the use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Preparation of levonorgestrel female contraceptive in situ gel injection implant

[0043] prescription:

[0044] Each g of levonorgestrel (LNG) in situ gel injection implant contains:

[0045] P(TMC-LLA): 174mg

[0046] LNG: 6mg

[0047] NMP: 820mg

[0048] Among them, the specification of P(TMC-LLA) is TMC:LLA=59:41 (molar ratio), and the weight average molecular weight (Mw) is 346,125.

[0049] After the P(TMC-LLA) was cut into pieces, weighed the prescription amount and added a certain amount of NMP to mix evenly, and stirred overnight at 37°C until a transparent and uniform solution was obtained. The resulting solution was heated at 65°C to remove air bubbles therein. After levonorgestrel is crushed through a 100-mesh sieve, the prescribed amount of levonorgestrel powder is added and dissolved in the above solution, stirred to obtain a transparent and uniform solution, and levonorgestrel for female contraception is obtained after γ-ray irradiation disinfection ...

Embodiment 2

[0051] Preparation of Testosterone Undecanoate Male Contraceptive In situ Gel Injection Implant

[0052] prescription:

[0053] Each g of testosterone undecanoate (TU) in situ gel injection implant contains:

[0054] P(CL-DLLA): 187.5mg

[0055] TU: 187.5 mg

[0056] NMP: 625mg

[0057] Among them, the specification of P(CL-DLLA) is CL:DLLA=80:20 (molar ratio), Mw=70357.

[0058] After the P(CL-DLLA) was cut into pieces, weighed the prescription amount and added a certain amount of NMP to mix evenly, and stirred overnight at 37°C until a transparent and uniform solution was obtained. The resulting solution was heated at 65°C to remove air bubbles therein. After testosterone undecanoate is crushed through a 100-mesh sieve, the prescribed amount of testosterone undecanoate powder is added and dissolved in the above solution, stirred to obtain a transparent and uniform solution, sterilized by γ-ray irradiation to obtain testosterone undecanoate in situ gel injection Implant...

Embodiment 3

[0060] Preparation of estradiol in situ gel injection implant

[0061] prescription:

[0062] Each g of estradiol in situ gel injection implant contains:

[0063] PTMC: 240mg

[0064] Estradiol: 6mg

[0065] NMP: 750mg

[0066] Among them, PTMC, Mw=48578.

[0067] After the PTMC is shredded, weigh the prescription amount and add a certain amount of NMP to mix evenly, and stir overnight at 37°C until a transparent and uniform solution is obtained. The resulting solution was heated at 65°C to remove air bubbles therein. After estradiol is crushed through a 100-mesh sieve, the prescribed amount of estradiol powder is added and dissolved in the above solution, stirred to obtain a transparent and uniform solution, and γ-ray irradiation is used to sterilize to obtain an estradiol in situ gel injection implant .

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PUM

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Abstract

The invention mainly provides an in-situ gel injection implant. The implant is mainly composed of drugs, homopolymers or copolymers taking lactide, caprolactone or trimethylene carbonate as the monomers, and an organic solvent, which is mutually soluble with water. The drug transmission system can be injected into the subcutaneous parts, muscles, or diseased regions, and then a solid, namely an in-situ controlled-release implant, is formed through the solvent exchange. Through adjusting the ratios and molecular weights of each monomer and the prescription composition, the drugs can be released from one month to one year.

Description

technical field [0001] The invention belongs to the field of sustained and controlled release pharmaceutical preparations, and specifically prepares an in-situ gel injection implant with a homopolymer or a copolymer of lactide, caprolactone, and trimethylene carbonate as monomers. Injection. Background technique [0002] Common chemically synthesized biodegradable polymers include aliphatic polyester, polycyano, acrylate, polyorthoester, polyε-caprolactone, polyurethane, polyamino acid, etc. The most widely used of these polymers are α-polyesters, such as polylactide (PLA), lactic acid-glycolic acid copolymer (PLGA) and lactide-caprolactone copolymer (P(CL / DL- LA)) and so on. They have good biocompatibility and can be biodegraded into lactic acid monomers after being implanted in the human body, and finally become CO after the tricarboxylic acid cycle. 2 and H 2 O, excreted through the lungs, kidneys, and skin. Therefore, according to the needs of treatment, choose poly...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K47/34
Inventor 杨丹张晓伟李建新关艳敏孟舒
Owner LIAONING RES INST OF FAMILY PLANNING
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