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Tteriparatide freeze-dried pharmaceutical composition and preparation method thereof

A technology of teriparatide and composition, which is applied in the field of teriparatide freeze-dried pharmaceutical composition and preparation thereof, can solve the problem of high difficulty in using pre-filled injection pen, unsuitable preparation into sustained-release preparation, poor patient compliance, etc. to reduce the risk of sterility, reduce the risk of bacterial infection, and improve compliance

Pending Publication Date: 2022-04-12
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is a risk of infection in multiple administrations, poor patient compliance, and often forgetting to administer
Storage and transportation at 2-8°C, and pre-filled injection pens are difficult to use, high in cost, and expensive;
[0008] 2) Preparation of microspheres can reduce the frequency of administration and the risk of infection, but its production cost is high, the price is expensive, and the therapeutic properties of teriparatide are not suitable for preparation into sustained-release preparations

Method used

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  • Tteriparatide freeze-dried pharmaceutical composition and preparation method thereof
  • Tteriparatide freeze-dried pharmaceutical composition and preparation method thereof
  • Tteriparatide freeze-dried pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Preparation: Weigh an appropriate amount of water to dissolve 5 mg of lactose and 50 mg of mannitol, dissolve the lactose and mannitol fully and uniformly, and mix to obtain a lactose-mannitol solution; weigh an appropriate amount of water to dissolve teriparatide raw materials, with a concentration of 2 mg / ml, after dissolving, add to lactose-mannitol solution, stir evenly to obtain lactose-mannitol-teriparatide solution; take appropriate amount of water to dissolve sodium acetate and glacial acetic acid, add lactose-mannitol-teriparatide after mixing In the solution, stir evenly, adjust the pH value to 4.0 with 10% sodium hydroxide or 10% hydrochloric acid according to the measured pH value, and continue stirring evenly. Weigh directly 0.5 mg of menthol and add it to the above solution, stir until it dissolves completely to obtain a composition solution, use a mould, pour the obtained composition solution into the mould, put it into a freeze dryer for lyophilization, ...

Embodiment 2

[0045] Preparation: Weigh an appropriate amount of water to dissolve 50 mg of lactose and 50 mg of mannitol, dissolve the lactose and mannitol fully and uniformly, and then mix to obtain a lactose-mannitol solution; weigh an appropriate amount of water to dissolve teriparatide raw materials, the concentration is 2 mg / ml, after dissolving, add to lactose-mannitol solution, stir evenly to obtain lactose-mannitol-teriparatide solution; take appropriate amount of water to dissolve sodium acetate and glacial acetic acid, add lactose-mannitol-teriparatide after mixing In the solution, stir evenly, adjust the pH value to 4.0 with 10% sodium hydroxide or 10% hydrochloric acid according to the measured pH value, and continue stirring evenly. Weigh directly 0.5 mg of menthol and add it to the above solution, stir until it dissolves completely to obtain a composition solution, use a mould, pour the obtained composition solution into the mould, put it into a freeze dryer for lyophilizatio...

Embodiment 3

[0047] Preparation: Weigh an appropriate amount of water to dissolve 10 mg of lactose and 100 mg of mannitol, dissolve the lactose and mannitol fully and uniformly, and then mix to obtain a lactose-mannitol solution; weigh an appropriate amount of water to dissolve teriparatide raw materials, with a concentration of 2 mg / ml, after dissolving, add to lactose-mannitol solution, stir evenly to obtain lactose-mannitol-teriparatide solution; take appropriate amount of water to dissolve sodium acetate and glacial acetic acid, add lactose-mannitol-teriparatide after mixing In the solution, stir evenly, adjust the pH value to 4.0 with 10% sodium hydroxide or 10% hydrochloric acid according to the measured pH value, and continue stirring evenly. Weigh directly 0.5 mg of menthol and add it to the above solution, stir until it dissolves completely to obtain a composition solution, use a mould, pour the obtained composition solution into the mould, put it into a freeze dryer for lyophiliz...

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Abstract

The invention discloses a teriparatide freeze-dried pharmaceutical composition and a preparation method thereof, and the teriparatide freeze-dried pharmaceutical composition comprises the following raw materials in parts by weight: 0.2 part of teriparatide, 50-150 parts of mannitol, 5-50 parts of lactose, 0.1-1 part of menthol, 0.1-0.5 part of sodium acetate, 0.1-0.5 part of glacial acetic acid, and a proper amount of a pH regulator for regulating the pH value to 3.0-6.0. The administration mode of the teriparatide freeze-dried pharmaceutical composition is sublingual administration, the formula of the teriparatide freeze-dried pharmaceutical composition provided by the invention does not contain a bacteriostatic agent, so that the toxicity to a human body is less, in addition, the administration mode of the teriparatide freeze-dried pharmaceutical composition is sublingual administration, injection administration is not needed, and the application range is wide. The pricking feeling caused by administration is reduced, the sterile risk in clinical use is reduced, and the compliance of a patient is improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a teriparatide freeze-dried pharmaceutical composition and a preparation method thereof. Background technique [0002] Teriparatide (Teriparatide) is the first new bone-forming drug approved by the US Food and Drug Administration (FDA). It is suitable for the treatment of osteoporosis in postmenopausal women with a high risk of fracture. and nonvertebral fracture risk. Teriparatide is an endogenous parathyroid hormone containing 34 amino acids. It has a 1-34 amino acid fragment in the N-terminal region with biological activity. Its molecular formula is C181H291N55O51S2, its molecular weight is 4177.77, and it has good water solubility. Teriparatide injection was approved for marketing by FDA in November 2002, followed by EMEA in June 2003, and PMDA in July 2010. In March 2011, Teriparatide Injection was approved to enter the Chinese drug market, and was approved by the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/26A61K47/10A61K47/12A61K38/29A61P19/10
Inventor 范忠实张伟明唐洋明余品香
Owner HYBIO PHARMA
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