In a major breakthrough, Mumbai’s Tata Memorial Center, in collaboration with IDRS Labs in Bangalore, has developed the nation’s first and only chemotherapy drug in liquid form: 6-mercaptopurine (6-MP). The syrup will be available in the market under the trade name ‘PREVALL’.
This is a critical drug used to treat Acute Lymphoblastic Leukemia (ALL) in children, the commonest form of blood cancer affecting children. Around 10,000 children in the age group of 1–10 years are diagnosed with ALL annually.
Although liquid formulations have been available in Europe and the US for a long time, they were not accessible in developing countries like India. The introduction of oral suspensions will effectively tackle the challenges related to dosage precision, tolerability, and flexibility. The Tata doctors say that the powder for the oral suspension can be reconstituted into a 100-ml oral suspension at a concentration of 10 mg/mL.
PREVALL has received regulatory approval from the national drug body, the Central Drugs Standard Control Organization (CDSCO). Prior to this, the Tata Memorial Center, the Advanced Centre for Training Research and Education in Cancer (ACTREC), Navi Mumbai, and IDRS Labs, Bangalore, had jointly published the results of the clinical study of the drug in the scientific journal Pediatric Blood and Cancer.
The powder for oral suspension is available with a syringe and Press-In Bottle Adapter (PIBA), which allows precise dosing according to the patient’s body weight or body surface area. This will help eliminate the risk of spillage and exposure of cytotoxic drugs to caregivers, as well as facilitate accurate administration.
Dr. S. D. Banavali, Director Academics, Tata Memorial Center, Mumbai, and a senior pediatric hemato-oncologist, said that the tablets are usually available in 50 mg formulations, while the dosage required for children is in the range of 22 ml or 37 ml. For the age group of 1.5–2 years old, there was a risk of overdosing or underdosing. Until now, the tablets were crushed or dispensed as alternate-day dosing, which were unideal practices. The liquid formulations provide better absorption too, he added further.
Dr. Girish Chinnaswamy, professor and head of the department of oncology, Tata Memorial Hospital, said that the liquid formulations will ensure maximum efficacy of the drugs, patient compliance, and dose optimization. Dr. Vikram Gota, professor of clinical pharmacology, ACTREC, further added that the powder for the oral suspension is formulated to ensure stability in hot and humid conditions.
The formulation was introduced at Tata Hospital in early December and will be available on the market very soon. Tata Hospitals further plans to collaborate with IDRS Labs to develop additional liquid syrups for children diagnosed with cancer.
(Inputs from various sources)
(Rehash/Dr. Sushmita Ganguli)