Creating Value with Tailored ODT Solutions
Increasing patient adherence to medication regimens remains a top priority in the pharmaceutical industry. Simultaneously, consumers/patients are looking for dosage forms that are easy to take and that will not disrupt their everyday “on the go” lifestyle. Orally disintegrating tablets (ODTs) can address both of these goals. However, ODT products can be challenging to formulate. Extensive experience in solving these formulation problems is essential to developing optimized ODT formulations that provide value to both drug makers and patients.
Patient Challenges with Tablets
Oral solid dosage (OSD) is the most popular dosage form overall, because OSD products are convenient, flexible and cost-effective. Tablets and capsules, however, can be difficult for some people to swallow, which can have a direct impact on their likelihood of taking their medication.
The inability to swallow tablets —referred to as dysphagia — primarily presents itself in pediatric and geriatric patient populations, but all age groups can be affected; at least 40% of adults have reported problems swallowing medication, with 8% skipping doses and 4% stopping treatment as a result.1 Organoleptic and sensory properties (e.g., taste, mouthfeel and odor) and convenience — the ease of integration of medication into daily routines — are also important to patients.
According to a 2015 report, the industry has been slow to address the issue of patient difficulties with swallowing tablets.2 The U.S. Food and Drug Administration (FDA) published a guidance on the desired size, shape and other physical attributes of generic tablets and capsules in June 2015.1 In the document, the agency states that: “We believe that tablets and capsules can be effectively developed and manufactured to minimize swallowing difficulties, which can encourage and improve patient compliance with medication regimens.”
ODT products are targeted to disintegrate in the mouth within 30 seconds without the need for water. Chewable and fast-melt tablets disintegrate in the mouth within 30–60 seconds during chewing. ODP products are designed for rapid dispersal in the mouth and are typically offered in stick packs.