Formulation of sustained-release diltiazem 120 mg tablets with excipients of xanthan gum

Abstract

    Diltiazem hydrochloride, a benzothiazepine derivative, is considered a safe and effective antihypertensive agent. The drug also has the advantage of having no side effects on kidneys and not causing metabolic disorders. However, a major drawback of diltiazem is that the half-life is only about 6 hours, so patients have to take the drug 3 to 4 times a day. In order to overcome the disadvantages of conventional tablets, the study has developed a sustained-release diltiazem tablet formulation with hydrophilic matrix system by wet granulation method using release control excipients such as xanthan gum and hydroxy propyl methyl cellulose (HPMC). The best formulation was obtained with diltiazem 120 mg and excipients: xanthan gum (50 mg), HPMC (20 mg), lactose (100 mg), Amidon (40 mg), Comprecel (70 mg), talc and magnesium stearate 2 % (ratio 1:1). The study also prepared and evaluated some basic quality standards of sustained-release diltiazem 120 mg tablets, as well as controlled drug release up to 8 hours ( not less than 65 %).