Quick-acting orally disintegrating tablet and powder based on novel porous lactose and microcrystalline mannitol auxiliary materials

Abstract

The invention provides a quick-acting orally disintegrating tablet and powder based on novel porous lactose and microcrystalline mannitol auxiliary materials, which is prepared from the following components in parts by mass: 0.5-60% of active pharmaceutical ingredient, 0-99.5% of the novel porous lactose (anhydrous alpha / beta mixed crystal lactose), 0-99.5% by mass of the microcrystalline mannitol(alpha / delta-mannitol mixed crystals) ; the quick-acting orally disintegrating tablet and powder based on the novel porous lactose and the microcrystalline mannitol auxiliary materials can be completely dissolved in the mouth within 2 seconds to 5 minutes, and effectively release active medicinal ingredients. The quick-acting orally disintegrating tablet and powder aims at the physical changes ofthe lactose and mannitol, so that the effect of uniformly and quickly releasing the orally disintegrating tablets is achieved; the method is practical in technology and can be industrialized easily.The quick-acting orally disintegrating tablet and powder directly or indirectly upgrades all existing orally disintegrating tablets and powders using the lactose and / or mannitol by upgrading auxiliarymaterials of the orally disintegrating tablets and powders.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a quick-acting orally disintegrating tablet and powder based on novel porous lactose and microcrystalline mannitol auxiliary materials. Background technique [0002] Orally disintegrating tablet is a new type of drug tablet that can quickly dissolve in saliva in the oral cavity. It is suitable for children, the elderly, the handicapped, stomach damage, difficulty swallowing medicine, mental illness, epilepsy patients, Alzheimer's disease, etc. It is also especially suitable for the case where the drug needs to be absorbed directly into the blood under the tongue. To achieve rapid dissolution, the powder used to prepare the tablet can also be used as a powder alone and taken directly. [0003] One of the most commonly used formulation techniques for orally disintegrating tablets is to make the drug into an amorphous form. For example, Poovizhi Ponnammal et al. published "Orall...

AI Technical Summary

Problems solved by technology

However, the lactose and mannitol used in the prior art are block-shaped grinding and sieving granules, and lactose and mannitol are mostly used as fillers, which have little effect on drug release

[0005] The development history of orally disintegrating tablets is relatively short, and the above conventional preparation methods have been registered in large quantities internationally, making it difficult to make creative achievements in drug improvement; and the improvement of drug formulations, such as changing the ratio of traditional Chinese medicine formulas, changing the ratio of excipients and mixing, is relatively lacking. Novelty; using too many excipients and components at the same time is not conducive to safety audit and toxicology research, and increases clinical difficulty

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