Halo Pharma announces the formation of its Pediatric Center of Excellence in support of the development and manufacture of dosage forms tailored for pediatric indications. Halo Pharma has been working closely with pharmaceutical companies to apply its expertise in formulation sciences and manufacturing capabilities to develop pediatric dosage forms (PDFs) of already approved adult dosage forms.
Pharmaceutical companies are often asked by the U.S. Food and Drug Administration to conduct clinical trials for pediatric indications of adult dosage forms. The advantages of developing PDFs include the potential for extended patent protection and to obtain expanded indications in pediatric populations.
In support of its Pediatric Center of Excellence, Halo Pharma has developed the infrastructure, process trains and equipment needed for efficient, cost-effective, and rapid production of small- to medium-scale cGMP clinical drug products that are used in pediatric clinical studies.
Halo Pharma has partnered with several pharmaceutical companies already to develop commercially viable PDFs that have received both U.S. and international regulatory approvals.
“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,” Lee Karras, CEO of Halo Pharma said. “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.”