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FDA Approves Cipla’s Drug Delivery System for Infants and Children Suffering from HIV

by Vishnuprasad on June 4, 2015 at 5:08 PM
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FDA Approves Cipla’s Drug Delivery System for Infants and Children Suffering from HIV

Cipla, the Mumbai-based pharma major, has received approval from the US Food and Drug Administration (USFDA) for a new drug delivery system.

According to the company, the system can be used in treating infants and children suffering from HIV.


The approval is for Lopinavir/ ritonavir 40mg/ 10 mg oral pellets for treatment for infants.

"The pellets are to be sprinkled on sweetened porridge for infants and administered to them. The pellets are produced by melt-extrusion technology and are enclosed in capsules," says a press release issued by the company.

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."

Cipla has been working for many years in collaboration with Diana Gibb, Professor of Epidemiology, Senior Program Leader and Honorary Consultant Pediatrician at Medical Research Council Clinical Trials Unit at University College London towards development of this novel 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.

Source: Medindia

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