Mouth cavity quick dissolving quick disintegrating freeze-dried tablet and its preparing method

A technology of oral instant and freeze-dried tablets, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, pill delivery, etc., can solve the problems of poor product appearance, increased dosage, poor mechanical strength, etc., and achieve a simple and practical preparation method , prevent "throat stuck, low manufacturing cost"

Inactive Publication Date: 2004-02-11
刘辉
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If there are too many solids, not only will it not be easy to distribute into the concave model made of plastic film, but the resulting product will have less pore network structure, which will not achieve the ideal rapid disintegration and instant dissolution effect
If the solid content is low, the product is too loose and the pores are too large. Although the disintegration speed in the oral cavity is fast, the product not only has poor appearance, but also has low mechanical strength, is easy to break, and is even difficult to take out from the mold.
The above-mentioned existing patent technology does not mention or is not clear about the content of the liquid to be distributed
In addition, although the above-mentioned existing patent technology has specified the amount of certain substances in the carrier (such as the main substances used as fillers-mannitol, gelatin, etc.), it does not take into account the medicinal active substances themselves, especially the one-time The fact that a l

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0027] Amoxicillin freeze-dried tablets for children, its formula is (500 tablets):

[0028] Amoxicillin 25g (calculated as anhydrous)

[0029] Mannitol 32g

[0030] Gelatin 2g

[0031] Macrogol 6000 3g

[0032] Orange essence 0.5g

[0033] Aspartame 2.5g

[0034]Methylparaben 0.21g

[0035] Ethylparaben 0.11g

[0036] Add pure water to 250ml

[0037] The preparation method of amoxicillin freeze-dried tablet for children comprises:

[0038] Step 1. Crush and sieve: Grind and sieve amoxicillin, orange essence, aspartame, methylparaben and ethylparaben respectively to make a fine powder with a particle size of about 50 μm.

[0039] Step 2. Preparation of suspension: Weigh each component according to the prescription amount, then add gelatin to 85% pure water and stir to dissolve at a temperature of about 60°C, then add mannitol and stir to dissolve, cool the solution to room temperature, and then Add the fine powder of amoxicillin and other compo...

Embodiment approach 2

[0043] Cough and expectorant freeze-dried tablets for children, the formula is (100 tablets):

[0044] Dextromethorphan Hydrobromide 0.5g

[0045] Guaifenesin 10g

[0046] Mannitol 6.5g

[0047] peach gum 0.5g

[0048] Cross-linked Sodium Cellulose 0.32g

[0049] Polyethylene glycol 6000 0.8g

[0050] Aspartame 0.8g

[0051] Pineapple essence 0.8g

[0052] Methylparaben 0.085g

[0053] Propylparaben 0.045g

[0054] Add pure water to 250ml

[0055] The preparation method of the freeze-dried tablet for relieving cough and eliminating phlegm for children is basically the same as the method for preparing the freeze-dried tablet of amoxicillin for children in Embodiment 1, and will not be repeated here.

Embodiment approach 3

[0057] Freeze-dried tablets of acetaminophen for children, its formula is (100 tablets):

[0058] Coated paracetamol powder 9.4g (8.0g of pure paracetamol)

[0059] Mannitol 4.0g

[0060] Glycine 3.0g

[0061] Gelatin 0.4g

[0062] Sodium saccharin 1g

[0063] pvp K30 0.2g

[0064] Lemon essence 0.3g

[0065] Methylparaben 0.085g

[0066] Propylparaben 0.045g

[0067] Add pure water to 80ml

[0068] The preparation method of acetaminophen freeze-dried tablets for children is basically the same as the preparation method of amoxicillin freeze-dried tablets for children in Embodiment 1, the only difference is: before step 2. preparing the suspension, use ethyl cellulose The acetaminophen powder was coated and taste-masked in plain and ethanol solution, and the coated acetaminophen contained 8.0 g of pure acetaminophen.

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Abstract

The oral cavity quick dissolving and quick disintegrating freeze dried tablet for children includes at least one medicinal active component and at least one medicinal stuffing, adhesive and other supplementary material. It is loose and porous tablet in network structure and prepared through common freeze drying process. The said medicinal active component may be different children's medicines, such as antibiotic, antipyretic, analgesic, cough stopping and phlegm eliminating medicine, cold medicine, etc. Bitter or excitant medicine may be coated and water insoluble medicine is prepared intofine powder of 50 micron below size for stable dispersion in liquid. The present invention has fast disintegration, no jamming in throat, simple preparation process and low cost.

Description

technical field [0001] The invention relates to a pharmaceutical dosage form, in particular to an oral instant-dissolving and rapidly disintegrating freeze-dried tablet for children and a preparation method thereof. Background technique [0002] As we all know, it is troublesome to let preschool children (especially infants under 3 years old) take pills orally. When feeding the medicine, the children cry and make parents anxious. In order to solve the above-mentioned problem of oral administration to children, manufacturers have developed many oral pharmaceutical dosage forms that are convenient for children to use, such as granules, chewable tablets, dispersible tablets, effervescent tablets and various liquid preparations. Although the above-mentioned pharmaceutical preparations have improved the compliance and convenience of children's oral administration to a certain extent, there are still deficiencies. Many infants and young children have already felt when their paren...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/166A61K31/43A61K31/4453A61P31/04
Inventor 刘辉
Owner 刘辉
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