Pediatric dosage forms (PDFs) are specially designed drug delivery systems that cater to the unique needs of children. These formulations consider factors such as the child’s age, weight, and ability to swallow, as well as the taste and appearance of the medication. The goal is to create a dosage form that is safe, effective, and acceptable to children, thereby improving adherence to medication regimens and ultimately, health outcomes.
Specialists and Facilities
We are equipped to take on pediatric dosage forms projects at any size or scale. They have the infrastructure and expertise to produce small-to-medium-sized batches needed for pediatric dosage forms and orphan drugs, and their capabilities extend to large-scale manufacturing.
Process
When a pharmaceutical company partners with us for pediatric dosage form development, we provide guidance on the patient population and the dosing targets based on age or weight groupings and clinical endpoints. Our formulation scientists and manufacturing teams process this data to identify the best options for reformulating a drug for the targeted pediatric patient population.
Pediatric-Friendly Formulations
Adults take tablets and capsules for their medication needs, but these dosage forms may not be suitable for children. From liquids and chewable tablets, syrups, suspensions, capsules, sachet/stick pack, patches and inhalers, pediatric dosage forms come in a variety of types, each with its own advantages and considerations for use. Developing these formulations requires specialized knowledge and expertise, as well as a deep understanding of the physiological and psychological differences between children and adults. It’s a challenging yet crucial part of pharmaceutical development, aimed at ensuring that even the youngest patients have access to the therapeutic benefits of modern medicine.
Taste Masking:
A major hurdle in getting children to take their medicine is the bitter taste of the drug. Our taste masking solutions and microencapsulation technologies can remove the bitter taste of your API and make it more palatable to pediatric patients.
Packaging
There are multiple ways to package pediatric drugs. We can package pediatric drugs in various formats optimized for ease of administration. These include various types of bottles for dispensing liquids or suspensions, capsules containing powders that can be opened and poured out into water or apple juice, and unique stick packs for packaging granules, powders, beads, or mini tablets.
Related Services
FAQs
Here are some frequently asked questions about Pediatrics
Renejix specializes in customized drug development for the pediatric population. Our services include the development and manufacturing of pediatric formulations such as orally disintegrating tablets (ODT), solutions, suspensions, oral gels, granules, and multi-particulate formulations like mini-tablets and coated beads. We also provide taste masking and primary packaging adapted to pediatric needs.
Safety and efficacy are our top priorities. We conduct rigorous pre-formulation and characterization of pediatric drug substances and products. Our R&D and ICH stability studies, both long-term and accelerated, are designed to meet the highest standards of pediatric drug development.
Absolutely. We provide comprehensive support for Pediatric Investigation Plans, ensuring that the necessary data are generated to determine the conditions under which a medicinal product may be authorized for the pediatric population, in compliance with EU and US regulations.
Developing oral suspensions for children can be challenging due to API solubility, stability, and taste. Renejix tackles these challenges with expertise in formulating oral suspensions that are palatable and safe for children, ensuring the right balance between efficacy and ease of administration.
We are a preferred partner due to our broad and deep expertise in small molecule oral dosage development, delivery technologies, and multi-modality manufacturing. Our state-of-the-art facilities and seasoned management team bring over 30 years of industry knowledge, guiding your programs with professionalism and insight.
We have over 300+ state-of-the-art equipment and facilities that can seamlessly adapt to your evolving needs from early development stages to large-scale production. Our scalable GMP manufacturing facilities are ideally suited for the development of your pediatric medicinal products.
Yes, we offer regulatory CMC support to ensure global compliance, streamline approvals, and support the product lifecycle with strategic regulatory planning and quality assurance.
Renejix boasts over 150+ analytical scientists who provide comprehensive analytical testing and method development for quality, validation, and compliance. Our analytical services are integral to the development and manufacturing process, ensuring the highest quality of pediatric formulations.
Yes, our end-to-end CDMO services cover all aspects from formulation to commercial manufacturing and post-life cycle management. We work closely with our clients to tailor our services to their unique project requirements, ensuring a smooth and efficient development process.