A patient taking a pill

Drugs will not work in patients who cannot or do not take them. Non- adherence to prescribed medication regimens is a major health issue and costs the health care system between $100 billion and $300 billion annually. Difficulty swallowing  tablets and capsules (dysphagia), is one of the major  factors affecting medication adherence and proper  medication administration. It is estimated that more  than 16 million people in the U.S. have some degree  of dysphagia. Many patients do not discuss this issue  with their doctors; instead they opt to skip doses or  manipulate their medication (by crushing or splitting  tablets or by opening capsules). Many modified  release formulations lose their desired therapeutic  profile when the dosage form is manipulated; thus,  resulting in ineffective therapy.

Although the industry has acknowledged the value  of putting the needs of the patient at the forefront  of drug product design, the reality is that their  insights tend to be incorporated late in the clinical  program, if at all. By using a structured toolbox  approach for incorporating the patient’s voice,  organizations can establish a patient-friendly target  product profile that includes recognizes factors such  as ease of administration, food effects, and dosing  frequency. Incorporating patient-focused dose design  principles early in the development process could  help developers avoid the need for expensive changes  later. This approach can improve regimen adherence  and reduce the number of patients dropping out of  clinical trials.

Despite these advantages of incorporating the patients’  voices, developers face steep challenges with designing drug products with optimal swallowability profiles,  especially in certain populations such as those who fall  in the pediatric or geriatric category.

Image showing medicine in hands

Companies may  lack the internal expertise, technologies, or resources  to incorporate patient factors that help patients  adhere to their dosing regimen at an early enough  stage. In a survey, nearly 70% of companies  looked for external assistance with pediatric dosage  form design.

Particularly in the past decade, industry and regulatory  stakeholders are rising to the challenge to identify  specific dose design flaws and gain insights into  how to design drug products that improve patient  acceptance and adherence. The FDA held a series of  meeting under the banner of the “The Voice of the  Patient.” These disease-specific meetings were  aimed to gather patients’ views on their diseases  and the therapies available to them. This August, the Renejix  launched a research collaboration with a small biotech company in Massachusetts, USA. The goal of  the collaboration is to address the specific challenges  of pediatric formulation and drug delivery, with an  eye toward developing child-friendly formulations.

THE PEDIATRIC CHALLENGE

Studies have shown that compliance rates in  children are as low, one suggesting as low as 12%. Children between the ages of two and six years can  ingest chewable tablets, soft shell capsules, orally  disintegrating tablets (ODTs), and fast-dissolving films  and granules- ODTs are a relatively popular dosage  form to address swallowability and administration  challenges in pedatric patients. Recent innovations  in ODTs, – include the masking of any unpleasant  taste and smell, and achieving longer duration to  counter frequent dosing due to slower release. One  study noted that patients prefer an ODT formulation  over a conventional tablet, with more the 75% of a sample group indicating that they found the ODT formulation easier to take than a conventional  tablet. Specifically, Renejix’s ODT is one breakthrough technology that has put patients’ needs  front and center. It disperses almost instantly in the mouth, with no water needed The superior dispersion speed of a sub-lingual  formulation is suitable for children because of the ease of  administration.

Image showing a patient taking a pill

Renejix provides a packaging solution for a wide range of powder, granule, liquid and  gel formulations. According to research by the Renejix  Institute and Rutgers University, caregivers commonly  lack the confidence or to accurately measure and  administer liquid medications to children. There  are many studies that demonstrate that measuring  devices are rarely dispensed with medicines, and that  there is a wide variance in the precision of liquid  dose measuring techniques. In addition, Renejix  offers the stick packs, which provide a convenient  packaging solution with pre-measured dosages and  easy administration.

Drug makers have a daunting task creating medicines,  from R&D to developing a marketing plan. However, it  is essential that they obtain the patients’ perspectives  early in the development process. It also is crucial  to keep in mind that certain patient populations  require additional consideration. Renejix stands  ready to help drug makers with this process.

ABOUT RENEJIX

Renejix is the leading global provider of advanced oral delivery technologies and development solutions for pharmaceuticals and consumer health products. With staff having over 30+ years serving the industry, Renejix has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply.

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Vineeth

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