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US 2015/0306097 A1Published application
Hydrazaline hydorchloride pellets and method of preparation
OwnerNavaneeta K. Gorrepatiinventor
Life of this patent
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Abstract
Embodiments of a hydrazaline hydrochloride composition for treatment of hypoertension in humans each provide sustained release of hydralazine hydrochloride administered in the form of pellets, granules and tablets. Methods of preparation are disclosed.
Claims31
A sustained release pharmaceutical composition of hydralazine hydrochloride comprising:
- 20-40% by weight of active drug content of hydralazine hydrochloride;
- 40-70% by weight of core content;
- 10-30% by weight of diluent;
- 1.5-3.2% by weight of binding agent;
- 4.2-6.8% by weight of control polymer;
- 0.22-0.53% by weight of film forming agent;
- 3.2-5.6% by weight of glidant;
- and
- a solvent.
6 more elements
An osmotic controlled drug release pharmaceutical composition of hydralazine hydrochloride comprising:
- 20-40% by weight of active drug content of hydralazine hydrochloride;
- 16-25% by weight of osmotic agent;
- 35-60% by weight of diluent;
- 8-10% by weight of binding agent;
- 18-25% by weight of disintegrant;
- 1.8% by weight of lubricant;
- a sufficient quantity of purified water as a solvent;
- and
- a coating solution comprising 3 grams of cellulose acetate, 0.2-0.4% by weight of sorbitol, 15% by weight of dibutyl phthalate and 100 ml of acetone, and purified water.
6 more elements
A multi-layered pharmaceutical composition of hydralazine hydrochloride comprising:
- 20-40% by weight of active drug content of hydralazine hydrochloride;
- 8-35% by weight of polysaccharide;
- 8-10% by weight of disintegrant;
- 2-3% by weight of lubricant;
- 10-25% by weight of binding agent;
- 3-8% by weight of hydrophilic polymer;
- 5-15% by weight of retard polymer;
- 10-12% by weight of enteric coated polymer;
- and
- 5% by weight of plasticizer.
7 more elements
A multiple unit pellet system pharmaceutical composition of hydrazaline hydrochloride comprising:
- 20-40% by weight of active drug content of hydralazine hydrochloride;
- 35-55% by weight of core sucrose;
- 10-12.5% by weight of binding agent;
- 5% by weight of hydrophilic polymer;
- 8% by weight of enteric coated polymer;
- 2% by weight of wetting agent;
- 1% by weight of coloring agent;
- 1% by weight of glidant;
- and
- a sufficient quantity of purified water as a solvent.
7 more elements
Dependencies are inferred from the claim text.