The US FDA has granted approval to Cipla's Lopinavir, Ritonavir (LPV/r) 40mg/ 10 mg oral pellets for paediatric specific treatment of HIV in infants. Cipla was working for many years in collaboration with Diana Gibb, professor of epidemiology, senior programme leader and honorary consultant paediatrician at Medical Research Council Clinical Trials Unit at UCL (University College London) towards development of this novel child-friendly formulation which has been approved by US FDA under the President’s Emergency Plan for AIDS Relief (PEPFAR) programme. This product is a first step in making accessible more modern and appropriately formulated treatment available to the most vulnerable of HIV patients – young children.
Jaideep Gogtay, Chief Medical Officer, Cipla said: "The oral pellets are the preferred antiretroviral in pediatric patents and this unique drug delivery system is a breakthrough in pediatric-specific treatment for infants. As of now, if this is to be administered to infants, you have to use it in a liquid form which is quite unpleasant and has about 40 per cent alcohol in it because syrups are typically made like that. So, what is currently available in not child-friendly formulation."
"The product was developed in-house but we worked with Prof Gibb to understand the dosing and how it has to be delivered and administered because she is an expert in Pediatric HIV," Gogtay added.
Cipla has long recognised the lack of access to life saving child-friendly formulations for the treatment of HIV, which prompted it to develop an innovative formulation of LPV/r oral pellets. The pellets are to be sprinkled on sweetened porridge and administered to infants. The pellets are produced by melt-extrusion technology and are enclosed in capsules.
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