Preparation method of fast-dissolving gefitinib tablet pharmaceutical composition

Abstract

The invention discloses a preparation method of a fast-dissolving gefitinib tablet pharmaceutical composition and belongs to the technical field of pharmaceutical preparations. The fast-dissolving gefitinib tablet pharmaceutical composition prepared by adopting the preparation method of the fast-dissolving gefitinib tablet pharmaceutical composition contains a gefitinib core and a film coating, wherein the film coating wraps the outer end of the gefitinib core, the outer surface of the gefitinib core is provided with a plurality of uniformly distributed hemispherical accommodating holes, expansion balls are inlaid and fixed in the hemispherical accommodating holes, the outer surfaces of the expansion ball are fixedly connected with a plurality of expanded and crack-guiding fibers, it can be achieved that an edible expansion agent is added in the gefitinib tablet, a large amount of gas is generated after acid-base chemical reaction in the presence of water, the fibers rapidly expand themselves and disintegrate to make the gefitinib tablet crack, the gefitinib tablet cooperates with a traditional disintegrating agent to make the gefitinib tablet rapidly crack into fine and small granular powder, the dissolution of gefitinib is promoted, accordingly the functional ingredients are rapidly absorbed by a patient, and a therapeutic effect is played.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of an instant gefitinib tablet pharmaceutical composition. Background technique [0002] Gefitinib tablets, indications: This product is suitable for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received chemotherapy. The previous chemotherapy mainly refers to platinum and docetaxel. The curative effect of patients with locally advanced or metastatic non-small cell lung cancer who have previously received chemotherapy is based on the survival advantage of the Asian subgroup in a large-scale placebo-controlled clinical trial. The shape is brown, round, film-coated tablets, this product The recommended dose is 250mg (1 tablet), once a day, orally, on an empty stomach or with food. If you have difficulty swallowing, you can disperse the tablet in half a glass of drinking water (non-carbonated be...

AI Technical Summary

Problems solved by technology

[0006] Gefitinib is a poorly soluble drug, and its solubility in aqueous solution is pH-dependent, that is, the lower the pH, the greater the solubility in aqueous solution, and it is almost insoluble in water with a pH value of about 7. According to the in vitro dissolution test, the gefitinib tablet of India NATCO Pharma Company only dissolves about 30% in 60 minutes, and the dissolution rate does not increase significantly in 90 minutes, indicating that a large amount of gefitinib is not released at all, and the therapeutically effective concentration cannot be reached.

[0007] The existing gefitinib tablets have a poor therapeutic effect on patients, and the drug effect achieved at a very high cost of treatment is far from reaching the curative effect of normal patients, especially for patients with poor gastric function. negligible

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