Fixed dose combinations for tuberculosis: Lessons learned from clinical, formulation and regulatory perspective

Abstract

Gravendeel JMT, Asapa AS, Becx-Bleumink M, Vrakking HA. Preliminary results of an operational field study to compare side-effects, complaints and treatment results of a single-drug short-course regimen with a four-drug fixed-dose combination (4FDC) regimen in

Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration

“…The new polypill-a fi xed-dose combination of aspirin, a cholesterol-lowering drug, a β blocker, and an angiotensin-converting-enzyme inhibitor 66,67 -might have the many noted advantages of fi xed-dose combinations for HIV, tuberculosis, and malaria, which have minimised prescribing errors and missed doses by patients while reducing costs by as much as 50% in some cases. 68 Furthermore, fi xed-dose combinations greatly simplify supply-chain management and patient education and counselling. 69,70 More studies of health and economic eff ects are needed to establish clearly whether the polypill for secondary prevention or high-risk primary prevention for cardiovascular diseases has advantages compared with use of multidrug regimens.…”

Substandard rifampicin based anti-tuberculosis drugs common in Ugandan drug market

“…The WHO emphasizes that anti-TB drugs should not be sold in the private sector due to their lack of patient supervision (Panchagnula, 2004). However, during the sample collection, the study team was alarmed to note that anti-TB drugs could be purchased from the private pharmacies without a prescription, a practice that undermines any efforts to regulate the use of these drugs exclusively in patients diagnosed with tuberculosis.…”

“…This is supported by the findings that some two-drug FDC and single formulation rifampicin products also failed the quality test. While the low rifampicin content in the FDC drugs pose risk of resistance development in patients and in the general population (Panchagnula, 2004;Long, 1979), it would however be most tragic if the single formulation of rifampicin was still being used for treatment of patients with tuberculosis in the private sector. This is because of lack of patient monitoring in the private sector exposing them to risks of inadequate treatment (Blomberg, 2001) .…”

“…A number of factors contribute to development of resistance to TB medications. Among these factors is use of substandard medications in TB treatment and lack of patient supervision (Pecoul, 1999;Panchagnula, 2004). iminomethyl rifamycin SV) is a semi synthetic macro cyclic antibiotic derived from Streptomyces mediterranei (Martindale, 2002).…”

Validation of Technology of Combined Two-Component Anti-Tb Drug "Rizef 150/75"

“…Изониазид и рифампицин -два самых мощных противотуберкулезных препарата. Совместное их ис-пользование позволяет уменьшить противотуберку-лезную терапию с 18 до 6 месяцев [1][2][3].Одной из важных проблем при комбинировании противотуберкулезных лекарственных препаратов в одной таблетке, является обеспечение биодоступности рифампицина, которая зависит от растворимости рифампицина в разных участках желудочно-кишечного тракта и его последующего всасывания. В известных комбинированных составах взаимное влияние ингредиентов приводит к существенному снижению биодоступности действующего начала, например, рифампицина, к повышению токсичности, что ухудшает противотуберкулезную эффективность и служит причиной возврата заболевания и развитию вторичной резистентности к лекарственным средствам.…”