Development of low-cost, weight-adjustable clofazimine mini-tablets for treatment of tuberculosis in pediatrics.

Clofazimine (CFZ) is an important component of the World Health Organization's (WHO) recommended all-oral drug regimen for treatment of multi-drug resistant tuberculosis (MDR-TB). However, the lack of a dividable oral dosage form has limited the use of the drug in pediatric populations, who may require lowering of the dose to reduce the likelihood of adverse drug events. In this study, pediatric-friendly CFZ mini-tablets were prepared from micronized powder via direct compression. Rapid disintegration and maximized dissolution in GI fluids was achieved using an iterative formulation design process. Pharmacokinetic (PK) parameters of the optimized mini-tablets were obtained in Sprague-Dawley rats and compared against an oral suspension of micronized CFZ particles to examine the effect of processing and formulation on the oral absorption of the drug. Differences in maximum concentration and area under the curve between the two formulations were non-significant at the highest dosing level tested. Variability between rats prevented bioequivalence from being determined according to guidelines outlined by the Food and Drug Administration (FDA). These studies provide an important proof-of-concept for an alternative, low-cost formulation and processing approach for the oral delivery of CFZ in manner that is suitable for children as young as 6 months of age.

Providing therapies to the opposite sex: views of complementary therapists working in clinical and private practice settings.

AIM: The study explored the experiences of working with the opposite sex as a therapists in a cancer care centre (CCC). METHODOLOGY: Therapists (n = 17) participated in three focus groups. Audiotapes were transcribed verbatim and analysed. RESULTS: Themes and sub-themes were identified; these related to maintaining safety, the relevance of location to how safe therapists felt when working with men, the therapeutic relationship, safety precautions and being vigilant. LIMITATIONS: The participants were from one cancer care centre in the North West of England. Only two males participated. CONCLUSION: This exploratory study identified that the majority of the participants in this study had concerns about safety related to the gender or sex of their patient or client. This was more of an issue in private practice with concerns centred on inappropriate sexual responses from male clients. This has implications for training and safety in establishing and maintaining a practice.