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

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...

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 large amount of drug is taken is also a skeleton material with a network structure, which brings difficulties to the preparation of an ideal freeze-dried drug dosage form

[0006] (2) The oral instant and quick-collapsing freeze-dried tablets have poor mechanical strength and poor crush resistance because they are in the form of a porous network structure. The amount of gelatin, some gelatin content accounted for more than 20%, some close to 40%

However, if the amount of gelatin is inappropriate, especially if the amount is too much, two problems will occur: one, if the amount of gelatin in the component is too much, the liquid to be dispensed at room temperature will be gelatinous (rather than a suspension or solution); Difficult to assign to multivariate sag models

The oral instant and quick-disintegrating freeze-dried tablets prepared in this way are difficult to quickly disintegrate and disperse in the oral cavity, and if used in children, it is easy to cause the risk of "throat entrapment"