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Pediatric formulation & product development

API & Drug Product Development >> Formulation Development >> Pediatric Formulation

Quotient Sciences has extensive knowledge and capabilities to provide unique integrated development solution of acceptable, palatable pediatric formulations which is a key feature within the industry, driven by patient needs and regulatory requirements.

Halo Pharma’s Pediatric Center of Excellence

API & Drug Product Development >> Formulation Development >> Pediatric Formulation

Halo Pharma’s Pediatric Center of Excellence is uniquely equipped to support the development and manufacture of dosage forms tailored for pediatric and other small patient populations.

CRO to Conduct Pediatric Formulation Screening Studies

API & Drug Product Development >> Formulation Development >> Pediatric Formulation

We offer Clinical Research Capabilities (CRO) to conduct Pediatric formulation screening studies to support scientific screening of various formulations during the development and selection stage.

Palatable Pediatric Drug Formulations

API & Drug Product Development >> Formulation Development >> Pediatric Formulation

Senopsys has been at the forefront of developing palatable, taste-masked pediatric drugs since enactment of the Best Pharmaceuticals for Children Act (BPCA) in 2002.

Pediatric Formulation & Product Development The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements. An efficient global CDMO working on Pediatric Formulation & Product Development has a good understanding of pediatric population needs, and presents extensive capabilities in integrated pediatric development solutions which are best suited for pediatric patients. The best choice of Pediatric Formulation & Product Development CMO should be using an integrated GMP manufacturing and clinical testing platform and should have established expertise in supplying GMP grade pediatric drug products for pediatric patient groups. It is also important to note that a well-qualified CDMO having expertise in pediatric Formulation & Product Development will perform rapid, adaptive trials in older humans to optimize taste attributes and/or PK performance to ensure clinical validation prior to proceeding to pivotal clinical trials with pediatric drug products. Choose a well-equipped Pediatric Formulation & Product Development CMO expert which will manufacture, package, release and supply GMP drug products ready for dosing on a worldwide basis, in line with your study and recruitment needs. It is even better when the pediatric formulation CDMO partner provides flexible options that range from a personalized, per-patient basis to traditional batch manufacturing. The top ranked pediatric formulation expert CDMO will be the one that supports regulatory processes for Pediatric Investigation Plans and Pediatric Study Plans as per the need of the client. A well-equipped CDMO focusing on pediatric Formulation & Product Development will provide the following benefits: • Accelerated timelines, reduction of costs and easing of regulatory burden • A single solution for an entire pediatric program, with only one contract and one point of contact • Rapid development and clinical testing of pediatric formulations • Comprehensive program design and regulatory support • Combined global expertise in formulation, manufacture and clinical development of pediatric medicines Regulatory expertise of CMO focused on pediatric formulation and pediatric drug development The CMO with in-depth expertise in pediatric formulation must have the understanding of the specific requirements that are mandatory for developing Medicines for Children and Neonates; the Pediatric Formulation & Product Development CMO should have a careful understanding of drug effects in pediatric populations along with other demographic considerations. The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed drug use are associated with a greater risk for harm than on-label drug use, a range of global initiatives have been developed to realize “better” medicines for children. This review describes the challenges and achievements of the European Union to realize this goal, with a focus on paediatric drug development and formulation design. In 2007, a European Paediatric Regulation was installed enforcing companies to consider children in the early development of drugs with a new drug substance, for a new indication or with a new route of administration. The European Paediatric Regulation requires companies to develop a paediatric investigation plan discussing the proposed clinical trials in children of different ages and the formulations for future marketing. Since 2013, the pharmaceutical design of any newly marketed paediatric drug should comply with the “Guideline on the Pharmaceutical Development of Medicines for Paediatric Use.” Pediatric Formulation & Product Development CMOs should, e.g. justify the route of administration, dosage form, formulation characteristics, safety of excipients, dosing frequency, container closure system, administration device, patient acceptability and user information. For Pediatric Formulation & Product Development CMOs, the guideline’s key aspects focus on novel formulations such as mini-tablets and orodispersible films, excipients with a potential risk for harm such as azo dyes and adequate user instructions. With a comprehensive knowledge of patient needs as well as regulatory requirements, a global pediatric formulation & product development expert understands that acceptability and palatability are key to your successful pediatric formulation. The established expertise and capabilities in commercial manufacturing services for pediatric drug products enables the CDMO to meet the complex technical challenges of pediatric products and provide a unique integrated development solution. Access a customized pharmaceutical development program for your pre-formulation, formulation, analytical characterization, product stability, process development, clinical trial supplies, regulatory needs and commercial production. Formulation development When a Pediatric Formulation & Product Development CMO houses a team of scientists having considerable experience in developing palatable formulations for the OTC and consumer health care industry, make sure they are known for their successfully developed pediatric pharmaceutical formulations which have received regulatory approval. Choose PharmaCompass to help you select from a full range of Pediatric Formulation & Product Development CMO partners that will enrich the process of new drug development with unique formulation approaches that focus on excipient selection and acceptability for the target age range. Make sure you partner with a CDMO that helps you design and develop age-appropriate formulations focused on patient and caregiver compliance. Check the full range of capabilities of the CDMO whether they are able to utilize taste-modifying and taste-masking techniques to ensure palatability, rapidly optimize and validate taste attributes, and PK performance using adaptive clinical trials. A significant attribute that your selected pediatric formulation CDMO should have is the capacity to apply modeling and simulation to understand drug dosage and performance, manufacture and supply products for dosing globally with only one to 3 weeks’ notice. Find a CDMO focused on pediatric formulation & product development that will perform commercial manufacturing for global markets, specifically for children, especially neonates and infants. Choose from a list of Contract manufacturers exhibiting capabilities in paediatric formulation & formulation using integrated GMP manufacturing and clinical testing platform, perform rapid, adaptive trials in humans to optimize taste attributes and/or PK performance to ensure clinical validation prior to proceeding to pivotal pediatric trials. The contract manufacturer that is working on finished formulations for pediatric drug products ensure that formulation compositions are modified in real time based on emerging clinical data. The present list of contract manufacturers working on paediatric drug formulations features companies that manufacture, package, release and supply GMP pediatric drug products ready for dosing on a worldwide basis in line with your study and recruitment needs. Our flexible options range from a personalized, per-patient basis to more traditional batch manufacturing. These customizable batch sizes conserve your API and reduce waste in the manufacturing process. Commercial manufacture of pediatric drug products – A qualified CMO ready to take up fresh formulation development products should have an accessible production facility that specializes in low-volume products and is fully inspected and approved by the MHRA. PIP/PSP regulatory support Choose a CDMO that will support regulatory processes for your Pediatric Investigation Plans and Pediatric Study Plans. An experienced expert CDMO working on pediatric drug product development should have history and the FDA of working on several pediatric projects and been very effective in translating our product concepts into successful prototype formulations. Any reputed formulation development expert CDMO that develops drugs for pediatric population tune in to the broader, long-term objectives of our projects and are agile in delivering specific work packages that will contribute to the overall project’s success. They are skilled in applying their extensive technical expertise and understanding of the full pediatric pharma development process. Importantly, they are great at adapting to change and tenacious when it comes to problem solving. They have proved to be an essential resource in developing a company’s pediatric portfolio.” Regulatory agencies worldwide encourage modeling and simulation to “get the dose right” and reduce risk in pediatric product development. Choose a CDMO partner whose methods of pediatric formulation development can utilize sparse data and prior information from pre-clinical studies, adult trials, literature data, and pediatric studies of related indications or drug actions. CDMO partners work to build that knowledge into models of patient physiology, drug actions and trial characteristics that enable us to develop and iterate clinical trial design, explore alternative dosing scenarios, in silico patient responses, drug-drug interactions, and whole trial outcomes. The “learn and apply” approach is repeated for each cohort, with additional modeling and simulation approaches used throughout the cycle. The European Commission and EMA have started to streamline application and implementation of the regulation, including making changes to deferrals, revisiting PIP processes and other aspects,” said Dehlinger-Kremer. A revised and revoked class waivers list will be effective this month, July 2018. The EU Commission and EMA also recently held a workshop with patients, academia, and health care professionals, discussing potential improvements to implementing the regulation. An action plan will be published later this year and commitment to implementation expected within two years. “For pediatric research, there is close collaboration between the US and the EU,” said Dehlinger-Kremer. “This has improved research in children significantly, and can only benefit the populations who need the medicines.” “Ignoring pediatric considerations is no longer an option for the development of new medicines, new indications, new dosing forms, new dosing regimens and also ensure challenges in formulation approaches to pediatric oral drug delivery are met. Ignoring pediatric considerations is no longer an option for the development of new medicines – though clinical trials in children are still not widely accepted by society, explains industry executive. A well-qualified pediatric drug development CDMO may have to choose global regulatory/medical writing consultancy that exhibits its expertise in pediatric drug development documentation spanning more than 15 therapeutic areas. The recent addition of renowned clinical trial operations technology now facilitates the eCTD submittal process, providing scalability and consistency for pediatric drug development CMOs. Choose from a list of contract manufacturers that provide an innovative solution to accelerate pediatric drug development by offering industry-leading, end-to-end support for all stages — from formulation development and clinical manufacturing, through conduct of all clinical trial phases, to commercial production. End-to-end pediatric development solution can provide one solution to execute an entire pediatric program with the potential for one contract and a single point of contact. This integrated offering accelerates cost-effective drug development by Increasing program efficiency — manufacturing and supply can be tailored for patient recruitment The established CDMO developing pediatric drug products one that is adapted to use methods which reduce Active Pharmaceutical Ingredient (API) use — The pediatric drug development CMO can develop and manufacture medicines in small, flexible and custom batches resulting in reduced overall API amounts and associated cost. PharmaCompass lists Formulation experts focused on pediatric formulation development services using unique methods that shortening the timeline between manufacture and dosing — decreasing the need for long stability studies, offering access to a global team of pediatric development experts and providing regulatory consulting through every step of the process. Partnering to accelerate pediatric drug development The well qualified CDMO offering pediatric formulation development services works to accelerate the development of new drugs for patients around the world by providing formulation development, clinical pharmacology, and clinical and commercial manufacturing services. Global CDMOs focused on pediatric drug development Services deliver an innovative portfolio of services and solutions that shortens development timelines, reduces costs and accelerates the delivery of new medicines while taking care of regulatory requirements. A pediatric development plan is required in the US, the Pediatric Study Plan (iPSP), and Pediatric Investigation Plan (PIP) in the EU, explained an pediatric formulation expert. Pediatric regulations in the US, including the Pediatric Research Equity Act (PREA), Best Pharmaceuticals for Children Act (BPCA), and the Food and Drug Administration Safety and Innovation Act (FDASIA) have been a success, she said. There is need for every pediatrics formulations services provider to have a good experience in regulatory compliance for developed pediatric drug products and strong core pediatric Formulation development experience for clinical trials with child populations. Designing pediatric clinical trials Still not widely accepted by society, there is often reluctance to involve children in clinical trials due to fears of harming children by exposing them to uncertain treatment effects. Moreover, investigators also are apprehensive of recruiting children because of the trial burdens, including an ‘overwhelming amount of information’ which must be provided to the families.