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European Pharmaceutical Contractor

Doing it for the Kids

Nilesh Nayak at Rubicon Research presents the reasons why pharmaceutical companies, both large and small, should reconsider their strategies in the paediatric market, highlighting new opportunities and developments

“Children are one third of our population and all of our future”; so said a Select Panel for the Promotion of Child Health, 1981. In spite of this, and contrary to the basic nature of the term ‘paediatric’, the paediatric market has not been growing. While the pharmaceutical industry continues to concentrate on medicines for the aging population, the paediatric market contributes an insignificant fraction of their growth plans and vision statements. Despite fluctuations of the actual size of the market, the general consensus is that it constitutes around 10 per cent of the total pharmaceutical market. Considering that children and infants form around 40 per cent of the total market in terms of population, the market share is disappointing. This makes the paediatric market akin to the other neglected markets of the world. The key factors contributing to this oversight are:

  • A relatively ‘small’ market size
  • Mostly off-patent drug use in the paediatric setting
  • No incentives for generic drug manufacturers to introduce paediatric drugs
  • Fewer chronic illnesses in children  Majority of the patients uninsured or underinsured
  • Higher per-patient costs as well as greater complexity of drug development


While doing research for this article, I spoke to a senior executive from a top pharma company that specialises in paediatrics and has a significant portion of its sales coming from this market. He strongly believed that the small size of the market was a big misconception, supporting his claim by rightly mentioning that if one considers the offlabel use of adult drugs for paediatric purposes, then the figure projected by the industry would be almost double the current estimate. However, off-label use is the primary reason for the adverse drug events, suboptimal dosing and noncompliance. We have to understand that a child is not a miniature adult but an individual with particular needs. One cannot administer lesser amounts of adult formulations to children and expect them to work in the same way.

With the ever-drying pipeline of blockbuster products and more emphasis on portfolio optimisation and lifecycle management of existing drugs, both Big Pharma companies – who considered this market as too small – and smaller companies – who considered it too problematic – are being forced to reconsider their viewpoints. In the blockbuster era, big pharma companies were offering multiple dosage form options for their molecules at the early stages of development. Subsequently, with increased pressures on R&D timelines and costs, they are not following this trend. However, outsourcing to specialised service providers, such as contract formulation development companies, can be a viable alternative. This way, companies do not lose the opportunity and still catch the timelines at an affordable budget. Outsourcing partners focusing on the paediatric delivery area can provide solutions to Big Pharma companies and speciality companies; they can sometimes offer more effective solutions, such as taste-masking or innovative flavour options.


Another fast-growing area with considerable market interest is the paediatric over the counter (OTC) segment. Though analgesics and cold/allergy/sinus remedies have been the largest contributors, vitamins, GI remedies and cough remedies show considerable promise in the OTC segment for paediatrics. Better-tasting products coupled with effective advertising have created big brands like McNeil’s Tylenol and Motrin (currently under FDA scanner), Schering Plough’s L’il Critters Vitamins and Children’s Delsym Cough Syrup from Adams Respiratory. These products have increased awareness of the paediatric segment, thereby generating interest in the market.

The prescription market for the paediatrics has also demonstrated growth, particularly in the following therapeutic areas:

  • Allergy and respiratory drugs
  • Anti-infectives
  • Cancer therapies
  • Cardiovascular drugs
  • Central nervous system drugs
  • Gastrointestinal drugs
  • Hormone drugs


The Food and Drug Administration Modernization Act of 1997 was introduced to allow legislation for the determination of paediatric applicability and adequate labelling instructions for children, and incentives were included for conducting the necessary studies on this demographic. Subsequently, additional incentives were provided in the Best Pharmaceuticals for Children Act (BPCA) in January 2002. This act provided the innovator a six-month extension of exclusivity if adequate paediatric studies were performed and allowed the FDA to formally request that such studies be performed.

In 2003, the Paediatric Research Equity Act (PREA) was passed, which provided the FDA with the authority to use bridging data from adult studies in the approval of paediatric medicines. These legislative supports, along with the Prescription Drug User Fee Act (PDUFA), encourage the development of paediatric drugs. The Food and Drug Administration Amendments Act (FDAAA) of 2007 extended and amended the BPCA and PREA, making it mandatory for companies to develop a paediatric formulation for drugs being developed if it was appropriate for children. Similarly, a legislation governing the development and authorisation of medicines for use in children was also recently introduced in the EU to stimulate paediatric formulation development, through a combination of market incentives and regulatory requirements.


Liquid formulations have usually been the ideal choice for delivering a paediatric dose. Children under 12 have difficulty swallowing capsules and tablets, whereas liquids can be easily administered and facilitate dose titrations. However, liquid formulations also have several disadvantages – the predominant one being the stability of the formulation in multi-dose units. This disadvantage leads to the use of preservatives in the formulation, and drug developers have to keep in mind the acceptable safety limits of preservatives for paediatrics.

The major challenge in developing paediatric formulations, when compared to adult formulations, is making the dosage more palatable for the child population considering their strong resistance and taste sensitivity towards medicine in general. This leads to the important aspect of taste-masking, which is a prerequisite for any paediatric oral formulation in all dosage forms.

Developing a drug product with acceptable taste and texture entails considerably more than just adding flavours and sweeteners to mask the bitter taste of the active drug. Though a single taste-masking technology might not be a solution in all cases, knowledge and experience of working with these platforms would be a good starting point. Two approaches are commonly used to overcome the bad taste of the drug. The first includes reduction of drug solubility in saliva – where a balance between reduced solubility and bioavailability must be achieved, while another is to alter the ability of the drug to interact with the taste receptors. The following factors also need to be considered:

  • Excipients used must have regulatory acceptability and no toxicity concerns
  • No effect on bioavailability of the drug
  • Cost-effective manufacturing process

By using an effective taste-masking approach, paediatric formulations can be offered in the following dosage forms:

  • Liquids
  • Suspensions
  • Chewable tablets
  • Orodispersible tablets
  • Tablets for suspensions or dispersible tablets
  • Powder for reconstitution


It can now be said that the previously unclear road leading towards the paediatric market is showing greater clarity in terms of regulatory guidelines. The economic barriers no longer look intractable: incentives are being offered by governments; the development pathway is becoming clearer; and various cost-effective and regulatory compliant taste-masking approaches for multiple dosage forms are being offered in this category. Big Pharma and speciality companies can collaborate with contract research companies specialising in the area of paediatric drug formulation in general, and taste-masking in particular, to create cost-effective products for this inevitably growing market.

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Nilesh Nayak is serving as the Business Development Manager for Rubicon Research, India. He is responsible for their contract research services from the EU and has also handled licensing deals. Before joining Rubicon in 2007, Nilesh worked in business development and licensing for a drug discovery company, and was responsible for in-licensing of products and technologies. A pharmacist by education, Nilesh completed his MBA degree and has over 12 years of experience in the pharma industry.

Nilesh Nayak
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