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Abstract:  There is an increasing need for an alternative route of isoniazid administration for prophylaxis and treatment of tuberculosis in children. The purpose of this study is to evaluate the in vitro release of isoniazid from extemporaneously compounded isoniazid suppositories with a goal of optimizing the suppository dosage form for this indication. Suppositories were compounded using three different base formulations (cocoa butter, Witepsol H15 Base F, and a combination of polyethylene glycols 3350, 1000, and 400). The release profiles of six compounded suppositories with isoniazid (100 mg) were tested with a United States Pharmacopeial Convention–approved dissolution apparatus. Isoniazid concentrations at predetermined time points were determined using high-performance liquid chromatographic analysis. The results show that drug release from the water-soluble base (mixed polyethylene glycols) was significantly greater than that from the lipophilic bases (cocoa butter and Witepsol H15). The percentage of isoniazid release from the polyethylene glycol suppository formulation (70 ± 1.4 mg/mL) was greater than that from the cocoa butter (55 ± 1.1 mg/mL) and Witepsol H15 Base F (18 ± 0.36 mg/mL) suppository formulations.

Related Keywords: Kristofer C. Hudson, PharmD, C. Scott Asbill, PhD, Andrew A. Webster, PhD, isoniazid, tuberculosis, rectal suppositories, intrarectal administration, prevention, children, cocoa butter, Witepsol H15 Base F, polyethylene glycol, formulations, excipients

Related Categories: EXCIPIENTS, FORMULATIONS, PEER-REVIEWED, DOSAGE FORMS/DRUG CARRIERS, INFECTIOUS DISEASE, PREVENTIVE MEDICINE/WELLNESS

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