Biological degradation type long-acting hypodermal contraception implant containing gestodene and preparation thereof

A gestodene and biodegradable technology is applied to the biodegradable long-acting subcutaneous contraceptive implant containing gestodene and the field of preparation thereof, and can solve the limitation of wide application of the implant, and the difficulty and increase of removal operation. Use cost and other issues to achieve the effect of strong drug activity, small dosage, and reduced incidence

Inactive Publication Date: 2012-05-09
LIAONING RES INST OF FAMILY PLANNING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 2. The implant is composed of 2 pieces and 6 pieces. The implantation operation is troublesome. Sometimes it is necessary to take out the implant or take out the carrier material when it expires due to side effects. Adhesion, wrapped by tissue, not easy to peel off when taken out, or the implant walks under the skin and cannot be touched, or the implant is too deep and not under the skin, making the removal operation more difficult
[0006] 3. Due to the side effects of the implant and the need to take it out when it is stopped, it increases the cost of use in clinical applications, which limits the wide application of the implant

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] 1. Melt the polymer degradation material trimethylene carbonate / p-dioxanone copolymer (P(TMC-co-PDO)) at 50-90°C in a heatable mixing mill, add the drug The enone crystalline powder (weight ratio 1:0.3) was mixed and ground evenly, put into an extruder, and extruded into a rod-shaped body with a diameter of 0.20 cm and a cut length of 0.6 cm, containing 4.38 mg of active drug.

[0033] Carrier polymer material trimethylene carbonate / p-dioxanone copolymer P (TMC-co-PDO) molecular weight: 50,000; viscosity: 0.60dL / g, of which trimethylene carbonate / p-dioxane The weight ratio between the ketone copolymers is 50:50.

[0034] 2. Pour the polymer material (P(TMC-co-PDO)) into the extruder at 30-40°C, extrude it into a drug release tube with a wall thickness of 0.03cm, and cut it into 1.0cm.

[0035] 3. Put the drug core prepared in 1 into the drug release tube of 2, and seal both ends with adhesive (the same material as the drug core). The actual effective length of the imp...

Embodiment 2

[0037] 1. Melt the polymer degradation material trimethylene carbonate / p-dioxanone copolymer (P(TMC-co-PDO)) at 50-90°C in a heatable mixing mill, add the drug The enone crystalline powder (weight ratio 1:0.25) was mixed and ground evenly, put into an extruder, and extruded into a rod-shaped body with a diameter of 0.18 cm and a cutting length of 1.0 cm, containing 7.3 mg of active drug.

[0038] Carrier polymer material trimethylene carbonate / p-dioxanone copolymer P (TMC-co-PDO) molecular weight: 80,000; viscosity: 1.00dL / g, of which trimethylene carbonate / p-dioxane The weight ratio between the ketone copolymers is 90:10.

[0039] 2. Pour the polymer material (P(TMC-co-PDO)) into the extruder at 30-40°C, extrude it into a drug release tube with a wall thickness of 0.05cm, and cut it into 1.4cm.

[0040]3. Put the drug core prepared in 1 into the release tube of 2, and seal both ends with adhesive. The actual effective length of the implant is 1.0 cm, and the average daily d...

Embodiment 3

[0042] 1. Melt the polymer degradation material trimethylene carbonate / p-dioxanone copolymer (P(TMC-co-PDO)) at 50-90°C in a heatable mixing mill, add the drug The enone crystalline powder (weight ratio 1:0.02) was mixed and ground evenly, put into an extruder, and extruded into a rod-shaped body with a diameter of 0.18 cm and a cutting length of 2.0 cm, containing 14.6 mg of active drug.

[0043] 2. Pour the polymer material (P(TMC-co-PDO)) into the extruder at 30-40°C and extrude it into a release tube with a wall thickness of 0.04cm and cut it into 2.4cm.

[0044] Carrier polymer material trimethylene carbonate / p-dioxanone copolymer P (TMC-co-PDO) molecular weight: 60,000; viscosity: 0.70dL / g, of which trimethylene carbonate / p-dioxane The weight ratio between the ketone copolymers is 60:40.

[0045] 3. Put the drug core prepared in 1 into the release tube of 2, and seal both ends with adhesive. The actual effective length of the implant is 2.0cm, and the average daily dru...

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Abstract

The invention relates to the technical field of contraceptive drugs, in particular to a biodegradation type long-acting subdermal contraceptive implant containing gestodene which uses the biodegradable polymer materials as the carrier for preparation and the preparation. The invention consists of the drug gestodene and the polymer biodegradable materials which are taken as a carrier (such as, trimethylene carbonate / p-Dioxanone copolymer (P(TMC-co-PDO))), a bar-shaped drug core is prepared by mixing the drug and the carrier, then the carrier materials are prepared into a drug delivery tube, then the drug core is arranged in the drug delivery tube, and the both ends are blocked by adhesives. The average daily drug delivery amount of the drug gestodene in the body is 10 to 30 micrograms. Theimplantation of one implant can be contraceptive for 1 to 2 years. The carrier materials can be degraded into small molecules after the release of the drug, the invention does not need to be taken out by the operation method, and the using cost is greatly reduced.

Description

technical field [0001] The invention relates to the technical field of contraceptive drugs, in particular, a drug containing gestodene is made of the drug gestodene as an active component in a contraceptive implant, and a biodegradable polymer material is used as a carrier. Biodegradable long-acting subcutaneous contraceptive implant and its preparation. Background technique [0002] At present, steroidal contraceptives mainly have oral and injection dosage forms. Because the former needs to be taken every day, medicines are often missed, resulting in contraceptive failure; the latter is administered by injection, which is troublesome to use, and has local pain and subcutaneous irritation symptoms. limit. In recent years, non-biodegradable long-acting subcutaneous contraceptive implants using silicone rubber as a carrier have been used clinically. Due to the large side effects of the drug, the implant needs to be removed by surgery when it is stopped. In addition, it needs ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/567A61K47/34A61P15/18
Inventor 李建新关艳敏杨丹孟舒
Owner LIAONING RES INST OF FAMILY PLANNING
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