|
|
Abstract
Formulation development of novel fixed dose combination (FDC) of lamivudine, nevirapine and zidovudine for pediatrics
Raghuvanshi R.S.1, Garg M.1, Jaiswal A.1, Juneja S.2, Chhabra A.2
Background: Antiretroviral therapy for children is long term and involves complicated multi-drug regimen admininistered through syrups (limitation :large volumes) or by breaking adult FDC tablets to suit requirements (limitations :dosage accurcay & palatablity). This may impair adherence to therapy and lead to drug resistance development.
Objective: To address the above issues, the three actives were formulated into FDC Tablets for Oral Suspension (TFOS). TFOS is designed to disintegrate quickly into a smooth uniform suspension in a small volume of liquid media like water and juices.
Method: The strength of active ingredients, based on treatment guidelines was selected in such a way so as to provide flexibility of dosing. Secondly to enhance accuracy of dosing, break line was introduced in the design. To enhance adherence and palatability flavoring agents preferred by children were incorporated.
TFOS contains the active ingredients in admixture with non-toxic pharmaceutical acceptable excipients which are suitable for its manufacture. These excipients may be for example inert diluents, granulating, lubricating and disintegrating agents. All selected excipients belong to “GRAS” Category.
During prototype development TFOS was subjected to various tests like dispersion time, uniformity of dispersion, taste, dissolution, potency and related substances tests.
Results: TFOS designed was
(1) Quickly dispersing into a smooth suspension in 5 ml of water within 2 minutes
(2) Having similar in-vitro dissolution media profile as that of individual products introduced simultaneously as separate liquids.
(3) Showing stability under accelerated conditions.
(4) Having palatable and acceptable orange flavor
Conclusions: All the physical parameters of TFOS were satisfactory which support the product feasibility for pediatric therapy using lamivudine, nevirapine and zidovudine FDC. The FDC will undergo Bioavailability/Bioequivalence studies to demonstrate that it attains the similar blood levels of the medicament as achieved when individual products are dosed simultaneously as separate liquids.The results of the same will be presented at conference.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
CDB541
Suggested Citation
"RaghuvanshiR.S., et al.
Formulation development of novel fixed dose combination (FDC) of lamivudine, nevirapine and zidovudine for pediatrics.
:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
CDB541"
|
|
|