Halo Pharma has unveiled the formation of its Pediatric Center of Excellence in support of the development and manufacture of dosage forms tailored for pediatric indications. Halo has been working closely with pharmaceutical companies to apply its expertise in formulation sciences and its integrated manufacturing capabilities across a broad range of scales and dosage forms to overcome the challenges in developing pediatric dosage forms (PDFs) of already approved adult dosage forms. Halo provides specialized contract development and manufacturing services that meet the regulatory requirements of the U.S., Canada, and Europe, where Halo Pharma is already manufacturing PDFs for commercial sale through its sponsors.

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 provides technical expertise needed to modify adult dosage forms for pediatric use. This may include reformulation to enable a lower strength or making changes to the adult dosage form to improve patient compliance by making the medication easier to take and/or taste better.

Halo Pharma has partnered with several pharmaceutical companies already to develop commercially viable PDFs that have received both U.S. and international regulatory approvals. In addition, the company currently has multiple clinical and commercial PDF programs underway. In nearly all cases, developing a PDF from an adult dosage form requires additional product development work. In many cases, it is necessary to provide the PDF in various strengths matched to different pediatric age/weight brackets. Halo Pharma has the capabilities to manufacture batches of PDFs that typically range in scale from 5 Kg to 1000 Kg, with many requiring multiple processing steps.

“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,” said Lee Karras, chief executive officer, Halo Pharma. “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.”