Mumbai: Doctors from Mumbai’s Tata Memorial Centre in collaboration with IDRS Labs in Bangalore have developed India’s first and only chemotherapy drug, 6-mercaptopurine (6-MP), to be available in a syrup form. This drug is crucial to combat Acute Lymphoblastic Leukemia (ALL), the commonest form of blood cancer affecting children.
Approximately 10,000 children in the age group of 1-10 years diagnosed with ALL are expected to benefit from the drug annually. The oral suspension effectively tackles various challenges associated with the existing tablet formulation, including issues related to dosage precision, flexibility, and tolerability. Liquid formulations of 6-MP have been available in Europe and US for a long time, but children in India and other developing countries didn’t have access to it, Tata doctors said.
The child friendly formulation is available in the form of a powder for oral suspension, commercially available under the trade name PREVALL. Tata doctors said that it can be reconstituted into a 100 ml oral suspension at a concentration of 10mg/ml.
“Up until now, less-than-ideal practices such as tablet crushing or resorting to alternate day dosing were employed to meet the specific dosing needs in children,” said Dr S D Banavali, director-academics, Tata Memorial Centre, Mumbai, and a senior paediatric hemato-oncologist.
Explaining why it’s a game changer, Banavali said that conventional tablets typically come in 50mg formulations, while children often require dosages in the range of 22ml or 37ml. “Given the necessity of taking the medicine for 1.5-2 years, there was a risk of underdosing or overdosing. Significantly, our observations indicate that syrup absorption is more effective,” he emphasised.
PREVALL has received approval from Central Drugs Standard Control Organization (CDSCO), the national drug regulatory body. Tata Memorial Centre, the Advanced Centre for Training Research and Education in Cancer (ACTREC), Navi Mumbai and IDRS Labs jointly published the results of the clinical study leading to regulatory approval in the scientific journal Pediatric Blood and Cancer recently. The formulation was introduced in Tata Hospital in early December, and shall be available in all major hospital pharmacies across the country very soon.
Dr Girish Chinnaswamy, professor & head, department of paediatric Oncology at Tata Hospital said that formulations such as PREVALL would help in ensuring dose optimisation, improving adherence, and maximising the efficacy of drugs.
PREVALL is accompanied by a syringe and a Press In Bottle Adapter (PIBA) that allow precise dosing tailored to a patient’s body weight or body surface area. These features not only help in accurate administration but also eliminate the risk of spillage and caregivers’ exposure to cytotoxic compounds.
Dr Vikram Gota, professor of clinical pharmacology, ACTREC, said that the powder for oral suspension is designed to ensure stability of the drug in hot/humid conditions and is quite distinct from the liquid formulation available elsewhere in the world.
Tata hospitals now plans to work with the company on developing more syrup formulations for paediatric cancer patients.
