#DDPEvent 2012: Developing Products for Pediatrics

Formulating for the Geriatric Population: Anticipating Polypharmacy and the Difficulty with Elderly Patient Compliance
Daniel Bar-Shalom, University of Copenhagen

It is critical to know how chemical entities will react with each other before you mix them. The combination of e two products that are not compatible – micro-capsulate them. Is it possible to make a combo product where we can put the drugs together in one formulation?

In order to gelling granulate, the following things are critical: micro-encapsulate, dispensing machine, a syringe (container), software can lead to the product in the future. It is important to find out the specification and then the question is whether or not we need to develop it or adapt it. How can you check the behavior of the drug particles in a gel?

Challenges in Pediatric Medication
Patrick Crowley

In terms of drug delivery to children, the problems are mainly focused in the fields of diverse/requirements of the amount of drugs. Children are not small adults when it comes to medication, scaled down doses for adults won’t properly treat their ailments. Some medications have been found to be more toxic in children than adults. 50% of drugs used in the EU have not been rigorously tested for children. Where is R&D Going in Developed countries? For the most part, into genetic clinical conditions like asthma and cancer. he developing world it’s environmental effects – nutrition and infectious diseases.

When looking formulating an adult medication to a pediatric medication, something to be considered include: solid to liquid forms, what the liquid vehicles would be, developing it so it has a good taste, and how self administration makes drug delivery a major issue for children as well as portability if dosage has to be frequent.

How does a company cope with poorly tasting drugs? It’s important to consider the bitterness threshold.The reduction of the level of drug in solution such that is below the bitterness threshold, it can then be formulated without bitterness. Then it is important to choose a soluble form to formulate by buffering a new liquid.

Forms that are key to pediatric drug delivery:

• - Needle free delivery – Parental dosage is a major concern with respect to Type 1 Diabetics. Looking for better delivery forms – like needle free delivery. Is it acceptable for children?
• - Transdermal delivery – it has become more prominent and successful way for delivery. Drug: low dose, hydrophelicic, small molecule, reasonable solubility in water Advantages: silent administration, infrequent dosing, sooth plasma profile, dosing can be terminated and patch can be adjusted to vary dose. 

A New Approach to Developing Drugs for Pediatric and Geriatric Markets
Peter R Joiner, CEO, Maderia Therapeutics

Adult medications do not fit children. New diseases like hypertension and making their way into the pediatric arena. Drugs intended for pediatrics and geriatrics are niche drugs and they need to be focused for use.

When working with children in clinical trials, three three people as opposed to one– the child and the parents. In the US, only 2/3rds of medication fail to have advice on child dosing. They previously didn’t run pediatric drug trials. New law “If a drug has a potential use in children, you must run a pediatric trial at the same time.”  When it comes to drugs and dosing, the us is not treating our younger and older populations appropriately with respect to drug use in the US. Taste masking and stability for 24 months are critical for a liquid medication.