title: A new micronized formulation of halofantrine hydrochloride in the treatment of acute Plasmodium falciparum malaria.
abstract: The current formulation of halofantrine hydrochloride has poor absorption and bioavailability. A newly developed micronized formulation was evaluated for efficacy, safety and tolerance in the treatment of acute Plasmodium falciparum malaria. The study was conducted at a plantation hospital in northern Tanzania, where chloroquine resistance is common. Sixty in-patients with mild or moderate malaria were treated with 375-750 mg micronized halofantrine hydrochloride given in 3 equal doses, 6 h apart. Patients were followed up for 28 d after therapy. Treatment was associated with rapid parasite clearance (mean clearance time = 34.8 h), fever clearance (mean time = 20 h), and clinical improvement (70% of patients were free of all presenting symptoms within 2 d). The formulation was well tolerated clinically, although 3 patients (5%) developed mild pruritus after treatment which may have been drug-related. Haematological and biochemical studies did not indicate any significant toxicity. One patient, whose immediate recovery was uneventful, was found to have a headache and low parasitaemia 3 weeks after treatment. He was readmitted to the study and treated as before. Parasitaemia, fever and headache cleared rapidly and he remained aparasitaemic for 28 d.
authors.affiliation: Division of Communicable Diseases, Royal Free Hospital School of Medicine, London, UK.
authors.forename: S H
authors.initials: SH
authors.lastname: Gillespie
authors.forename: E P
authors.initials: EP
authors.lastname: Msaki
authors.forename: A
authors.initials: A
authors.lastname: Ramsay
authors.forename: F I
authors.initials: FI
authors.lastname: Ngowi
authors.forename: R
authors.initials: R
authors.lastname: Fox
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000962:Antimalarials / Q000737:chemistry* / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical; D002648:Child; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000188:drug therapy; D005500:Follow-Up Studies; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010616:Phenanthrenes / Q000737:chemistry* / Q000627:therapeutic use
chemical_list: D000962:Antimalarials; D010616:Phenanthrenes; C023768:halofantrine