PENDOPHARM launches prpdp-AMLODIPINE Oral Solution for the treatment of hypertension in childrenPrint
Montreal, October 9, 2019 – PENDOPHARM, a division of Pharmascience is proud to launch prpdp-AMLODIPINE 1 mg/mL Oral Solution. The first of its kind in Canada, prpdp-AMLODIPINE Oral Solution is a brand new, easy-to-administer pediatric formulation of this calcium channel blocker (CCB) used as an antihypertensive agent in children aged 6 years and older as well as in adults.
In the absence of an oral solution, Amlodipine has typically been compounded by hospital or community pharmacists for children. Compounded preparations are accepted in Canada as long as there is no Health Canada approved manufactured formulation of the product available. prpdp-AMLODIPINE Oral Solution addresses this problem by offering a new preparation manufactured according to Canadian Good Manufacturing Practices (GMP), ensuring a high-quality product for patients.
“Adult formulations are not ideal for administration to children. This requires pharmacists to crush and dissolve part of the tablet or capsules in a liquid to achieve the required strength for the child based on weight, and to make it easier for them to swallow. prpdp-AMLODIPINE accounts for this in a ready-to-use formulation designed with the needs of pediatric patients in mind.” explains Jean-François Lemieux, Vice President and General Manager, PENDOPHARM, “In order to meet children’s needs with regards to taste acceptance, route of administration, dosing concentrations, ease of dosing, stability and bioavailability, special pediatric formulations are required. prpdp-AMLODIPINE Oral Solution fulfills all of these patient needs.”
The need to develop pediatric formulations for Amlodipine was uncovered by a pan-Canadian pediatric hospital survey conducted by the CHU St-Justine Hospital’s Rosalind & Morris Goodman Family Pediatric Formulations Centre in 2017 on the drugs most in need of a pediatric formulations. prpdp-AMLODIPINE Oral Solution is the first product PENDOPHARM has launched to meet this unmet medical need.
“prpdp-AMLODIPINE Oral Solution is the start to improving accessibility to pharmaceutical treatment by children suffering from hypertension,” added Jean-François, “We need to improve existing drug formulations to ensure they are specifically adapted to the needs of children, who are typically neglected when it comes to new drug development. It is crucial to increase public awareness as there continue to be too many hurdles for the development of pediatric formulations.”
prpdp-AMLODIPINE solution is administered using a syringe and adaptor to ensure accurate dosage. It does not need to be shaken, is tasteless, alcohol-free, sugar-free and without propylene glycol.