Oral loratadine disintegrating tablet and its prepn

A technology of orally disintegrating tablets and loratadine, which is applied in the field of medicine, can solve the problems of inconvenient taking, slow onset of effect, and inability to quickly absorb the drug, and achieve convenient oral administration, rapid onset of effect, and improved bioavailability Effect

Active Publication Date: 2006-03-01
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current loratadine is generally an oral gastric-soluble preparation, the drug cannot be absorbed quickly, the onset of action is slow, and it is inconvenient to take, especially for patients with poor swallowing function due to allergic diseases

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Example 1: In this example, 1000 orally disintegrating tablets of loratadine (specification: 0.25g) were prepared, using the following ingredients:

[0018] Material name Feed amount

[0019] Loratadine 250g

[0020] Mannitol 420g

[0021] Microcrystalline Cellulose 150g

[0022] Crospovidone 70g

[0023] Aspartame 20g

[0024] Mint essence 10g

[0025] Silica 20g

[0026] Magnesium Stearate 5g

[0027] Process steps: raw materials, auxiliary material granules, adding aspartame, peppermint essence, silicon dioxide, and magnesium stearate, mixing evenly, compressing into tablets, and packaging.

[0028] The mouthfeel, oral disintegration time, disintegration time limit, and friability were measured for the samples of the above prescription.

[0029] Test items

[0030] great taste

[0031] Oral disintegration time limit 28 seconds

[0032] Disintegration time limit 19 seconds

[0033] Friability 0.5%

Embodiment 2

[0034] Example 2: In this example, 1000 orally disintegrating tablets of loratadine (specification: 0.25g) were prepared, using the following ingredients:

[0035] Material name Feed amount

[0036] Loratadine 250g

[0037] Sorbitol 400g

[0038] Glucose 80

[0039] Sucrose 70g

[0040] Croscarmellose Sodium 60g

[0041] Stevioside 25g

[0042] Sweet orange essence 10g

[0043] Silica 20g

[0044] Sodium Octadecyl Fumarate 5g

[0045] Process steps: raw materials, auxiliary material granules, adding stevioside, sweet orange essence, silicon dioxide, sodium stearyl fumarate, mixing evenly, compressing into tablets, and packaging.

[0046] The mouthfeel, oral disintegration time, disintegration time limit, and friability were measured for the samples of the above prescription.

[0047] Test items

[0048] great taste

[0049] Oral disintegration time limit 25 seconds

[0050] Disintegration time limit 16 seconds

[0051] Friability 0.6%

Embodiment 3

[0052] Example 3: This example prepared 1000 orally disintegrating tablets of loratadine (specification: 0.25g), using the following ingredients:

[0053] Material name Feed amount

[0054] Loratadine 250g

[0055] Mannitol 200g

[0056] Sucrose 220g

[0057] Gelatin 50g

[0058] Hydroxyethyl Cellulose 40g

[0059] Mint essence 10g

[0060] Process steps: raw materials and auxiliary materials are dissolved in water, fully mixed, added to the mold, placed in a freeze dryer to freeze at low temperature, vacuumed until the material is dry, and sealed for packaging.

[0061] The mouthfeel, oral disintegration time and disintegration time limit were measured for the samples of the above prescription.

[0062] Test items

[0063] great taste

[0064] Oral disintegration time limit 19 seconds

[0065] Disintegration time limit 14 seconds

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PUM

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Abstract

The present invention belongs to the field of medicine technology, and is especially oral loratadine disintegrating tablet for treating allergic diseases and its preparation process. The oral loratadine disintegrating tablet includes loratadine as effective medicine component, and excipient mixture comprising disintegrating agent, stuffing, soluble polyol and penetrant. The oral loratadine disintegrating tablet consists of loratadine 20-50 wt%, disintegrating agent 5-15 wt%, stuffing 10-30 wt%, soluble polyol 30-60 wt%, and penetrant 1-5 wt%. The oral loratadine disintegrating tablet, after being disintegrated fast, can cover gastrointestinal mucous membrane widely, and has fast acting, no first pass effect, high bioavailability, and convenient taking.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a loratadine orally disintegrating tablet for treating allergic diseases and a preparation method thereof. Background technique [0002] Anaphylaxis is an acute, systemic, severe and even life-threatening allergic reaction that occurs when a patient is exposed to the same allergen again after being previously sensitized by an allergen. Symptoms of an allergic reaction can appear immediately or within 2 hours of exposure to an allergen. Patients feel unwell, irritated, palpitations, tremors, flushed and itchy skin, tinnitus, coughing, sneezing, urticaria, edema, or dyspnea caused by asthma and tracheal obstruction, and cardiovascular system can occur without respiratory symptoms. Exhausted. Cardiovascular or respiratory system symptoms may usually appear when an allergic reaction occurs, but the symptoms of the two systems do not appear at the same t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/445A61K9/20A61P37/08
Inventor 范敏华
Owner HAINAN PULIN PHARMA
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