A stable tablet-in-tablet composition for nausea vomiting in pregnancy
AssigneeAkums Drugs & Pharmaceuticals Limited
InventorsSanjeev Jain, Arun Chaudhary, Mukesh Dhiman
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Abstract
The present invention provides a stable pharmaceutical composition comprising fixed dose combination of doxylamine succinate and pyridoxine hydrochloride for effective treatment of nausea vomiting in pregnancy wherein the stable dosage form is a tablet-in-tablet formulation. The tablet-in-tablet dosage form of the present invention shows dual release having delayed release inner core table comprising doxylamine succinate and pyridoxine hydrochloride and an immediate release outer tablet compressed over inner tablet comprising doxylamine succinate and pyridoxine hydrochloride.
Claims12
A tablet-in-tablet dosage form comprising:
- a. an inner core tablet comprising from about 10 to 20 wt. % Doxylamine and/or a pharmaceutically acceptable salt thereof and from about 10 to 20 wt. % Pyridoxine and/or a pharmaceutically acceptable salt thereof based on total weight of inner core tablet;
- b. an outer shell comprising from about 1 to 10 wt. % Doxylamine and/or a pharmaceutically acceptable salt thereof and from about 1 to 10 wt. % Pyridoxine and/or a pharmaceutically acceptable salt thereof based on total weight of outer shell
- wherein outer shell is compressed over inner core tablet.
A tablet-in-tablet as claimed in previous claims comprises an inner core having:
- a. From about 15.5 wt. % Doxylamine succinate and 16.92 wt. % Pyridoxine hydrochloride based on total weight of inner core tablet;
- b. From about 0.75 wt. % Polyvinylpyrrolidone (PVPPK-30) based on total weight of inner core tablet as binder;
- c. From about 5-40 wt. % microcrystalline cellulose, starch and Dibasic calcium phosphate based on total weight of inner core tablet as diluents;
- d. From about 0.5-5 wt. % of croscarmellose sodium, crosspovidone and sodium starch glycollate based on total weight of inner core tablet as disintegrant;
- e. From about 1.89 wt. % of colloidal silicon dioxide based on total weight of inner core tablet as glidant;
- f. From about 0.90 wt. % of Sodium Lauryl sulfate based on total weight of inner core tablet as wetting agent;
- g. From about 1.13 wt. % of Magnesium stearate based on total weight of inner core tablet as lubricant;
- h. From about 5.69 wt. % of Eudragit L as enteric coated polymer which provides delayed release of active agents.
A tablet-in-tablet as claimed in previous claims comprises an outer shell having:
- a. From about 1-10 wt. % Doxylamine succinate and Pyridoxine hydrochloride based on total weight of outer shell and;
- b. From about 10-50 wt. % microcrystalline cellulose, starch and Dibasic calcium phosphate based on total weight of outer shell as diluents and;
- c. From about 0.5-5 wt. % croscarmellose sodium based on total weight of outer shell as disintegrate and;
- d. From about 0.5-5 wt. % Polyvinylpyrrolidone (PVPPK-30) based on total weight of outer shell as binder and;
- e. From about 0.05-2 wt. % magnesium stearate and talcum based on total weight of outer shell as lubricant and;
- f. From about 0.5-3 wt. % colloidal silicon dioxide based on total weight of outer shell as glidant
A tablet-in-tablet dosage form wherein the dosage form as claimed in any of the above claim, wherein the outer shell is multi-layered more preferably bi-layered.
A tablet-in-tablet dosage form as claimed in any of the above claims, wherein the dosage form is used for the treatment of nausea and vomiting in pregnancy.
Dependencies are inferred from the claim text.