Loratadine lyophilized tablets and preparation method thereof

A technology of loratadine and dry tablets, which is applied in the field of loratadine freeze-dried tablets and its preparation, can solve the problems of obvious side effects and low bioavailability, and achieve the effect of no gritty feeling and good taste

Active Publication Date: 2012-05-16
BEIJING QUANTUM HI TECH PHARMA TECHCO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved by the present invention is aimed at the low bioavailability of loratadine and the shortcomings of obvious side effects. In order to prepare a preparation of loratadine with high bioavailability, small side effects and enhanced curative effect, the application provides a kind of The prescription and preparation method of loratadine freeze-dried tablets which have defects existing in the prior art are improved, and by adopting suitable excipients and specific dosage ratios of excipients and loratadine, a product with high bioavailability and obvious side effects is prepared. Loratadine freeze-dried tablets with reduced and improved curative effect

Method used

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  • Loratadine lyophilized tablets and preparation method thereof
  • Loratadine lyophilized tablets and preparation method thereof
  • Loratadine lyophilized tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0105] The preparation formula of the present invention is made up of following components:

[0106]

[0107]The specific preparation method is as follows: add loratadine, glycine, and pullulan to the fully dissolved xanthan gum solution, and mix to form a uniform solution; after the solution is degassed, it is accurately injected into the mold; After pre-freezing at -40°C to -170°C for 1 to 60 minutes, transfer to a freeze dryer, and freeze-dry at a pressure of 0.01 mbar to 10 mbar and at a temperature of -30°C to 30°C for 1 to 10 hours to obtain this product Invented loratadine freeze-dried tablets; after the pre-freezing step in the above method, the step of ice crystal incubation can also be added before being transferred to the lyophilizer, that is, the mold filled with the solution after the pre-freezing is put into -5 ℃ ~ -60 In the low temperature environment of ℃, the time is 5~15h.

Embodiment 2

[0109] The preparation formula of the present invention is made up of following components:

[0110]

[0111] The specific preparation method is as follows: add the loratadine, mannitol, and pullulan in the above-mentioned amounts into the fully dissolved xanthan gum solution, and mix to form a homogeneous solution; the rest of the preparation method is the same as in Example 1.

Embodiment 3

[0113] The preparation formula of the present invention is made up of following components:

[0114]

[0115] The specific preparation method is as follows: add the above-mentioned amount of loratadine, glycine, mannitol, pullulan, sodium alginate, and peppermint essence to the fully dissolved konjac gum solution, and mix to form a uniform solution; All the other preparation methods are the same as in Example 1.

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Abstract

The invention relates to loratadine lyophilized tablets, and a lyophilization prescription and a technology thereof. The loratadine lyophilized tablets provided by the invention are prepared from a main medicine loratadine and medicinal auxiliary materials. When the tablets are taken, no water is used, and the tablets disintegrate rapidly in mouths. Therefore, the tablets are suitable for patients with swallowing difficulties such as old people and children. Also, the tablets are suitable to be used in trips with water source shortages. The tablets are advantaged in convenient administration, fast absorption, small first-pass effect, and small irritation to gastrointestinal mucous membranes. The market prospect of the tablets is wide. With the lyophilized tablets provided by the invention, side effects of loratadine can be substantially reduced. Also, the invention relates to a preparation method of the loratadine lyophilized tablets.

Description

Technical field: [0001] The invention relates to a loratadine freeze-dried tablet and a preparation method thereof, in particular to a loratadine freeze-dried tablet prepared by a freeze-drying method. Background technique: [0002] Loratadine, the chemical name is 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene )-1-piperidinecarboxylic acid ethyl ester. It belongs to the tricyclic long-acting oral second-generation antihistamines. Clinically, it is mainly used to relieve symptoms related to allergic rhinitis, such as sneezing, runny nose and nasal itching, nasal congestion, and eye itching and burning sensation. It is also suitable for the relief of symptoms and signs of chronic urticaria, pruritic skin diseases and other allergic skin diseases. Within the therapeutic dose range, it has no cardiotoxic effect, does not easily pass through the blood-brain barrier, and has no central sedative effect. It is the most widely used antihistamine drug. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4545A61K47/36A61P11/02A61P17/00A61P17/04A61P37/08
Inventor 王丛威王洪飞周立运王彦峰王丽滨
Owner BEIJING QUANTUM HI TECH PHARMA TECHCO
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