Halo Pharma launched its Pediatic Center of Excellence today to support the development and manufacturing of drugs tailored for pediatric indications. The company said it will use the manufacturing facility to continue working with pharmaceutical companies to develop pediatric dosage forms of already-approved adult drugs.
When the FDA requests that a company conduct clinical trials for pediatric indications of adult dosage forms, the pharma companies have to reformulate their therapeutics. Halo Pharma has the infrastructure and equipment needed for efficient production of small- to medium-scale cGMP clinical drug products for pediatric clinical trials, according to the company.
Reformulating adult dosage forms for kids can involve processes like lowering the drug’s strength and improving the taste to boost patient compliance.
The company said it has partnered with several, unnamed pharmaceutical companies already to develop pediatric dosage forms and that it has multiple ongoing clinical and commercial programs.
“Our formulation development and clinical manufacturing capabilities can support a variety of oral solid and liquid dosage forms suitable for pediatric applications, such as granules produced using fluid bed technology and mini-tablets that can be packaged into stick packs, powder in bottles for reconstitution, and our liquid products, which are typically oral solutions and suspensions that can also be time release-based,” CEO Lee Karras said in prepared remarks. “We offer our customers over 40 years of commercial drug manufacturing experience and a proven track record of approvals with regulatory agencies around the world.”