Difficulty swallowing tablets and capsules, also known as pill dysphagia, affects a significant percentage of the population. Reports estimate between 10–40% struggle swallowing tablets and capsules, especially larger ones (Source).
This article will explore design considerations formulators and manufacturers can use to optimize swallowability pharmaceuticals and dietary supplementsPatients may struggle to swallow tablets and capsules for a variety of reasons, often involving a combination of physical, psychological, and formulation-related factors.
As a result of swallowing difficulties, patients may delay doses, modify their medication by crushing tablets, or avoid taking it altogether. This non‑adherence is associated with poorer treatment outcomes and increased healthcare utilisation and costs. For over‑the‑counter (OTC) medicines and dietary supplements, these challenges can also translate into reduced consumer confidence, a negative brand experience, and ultimately lost sales due to discontinued or inconsistent use.
Swallowability is influenced by multiple design attributes. While patient physiology and perception play an important role, the physical design of the dosage form itself is a critical and controllable factor. When developing tablets and capsules, manufacturers should consider four key design elements:
Tablet size and shape are among the most influential determinants of swallowability. Larger tablets are more likely to trigger gag reflexes, create anxiety, or become lodged in the throat or oesophagus, while poorly designed shapes can increase friction during swallowing.
Thoughtful optimization of size and shape early in development can significantly reduce adherence challenges.
Tablet coatings play a central role in improving swallowability by addressing both mechanical and sensory challenges.
Evidence consistently shows that coated tablets are perceived as easier to swallow than uncoated equivalents, with improved patient acceptance and willingness to continue therapy.Taste masking is another critical benefit of coatings, as bitterness or unpleasant API flavours can provoke aversion or gag reflexes before swallowing even occurs.
Selecting the right coating system allows manufacturers to enhance patient experience without compromising stability or release performance. For a deeper overview of coating technologies and their functional benefits visit our article What Types of Coatings Are Used in the Pharma Industry.
Color is often viewed as a branding element, but it can also influence swallowability and patient perception. It is recommended to conduct patient or consumer preference studies as color preferences vary according to age, gender and geographic market.
Consistent and distinctive color choices can support brand recognition, help differentiate strengths or formulations, and reduce confusion for patients managing multiple medications. For OTC medicines and dietary supplements in particular, color plays an important role in shaping consumer expectations, reinforcing brand identity, and contributing to a positive overall product experience when combined with appropriate coatings and surface finishes.
Sensory perception begins before swallowing, and taste and smell can strongly influence whether a patient is willing to take a tablet or capsule at all.
Effective flavour and aroma masking supports a more positive first impression and reduces the likelihood of delayed or skipped doses.
When tablet size becomes a barrier to patient acceptability—typically for tablets weighing more than 1 g—formulators can explore adjustments to the core formulation to help reduce overall tablet mass without compromising performance. One effective strategy is the use of multifunctional excipients, which can fulfil multiple roles within the formulation. For example, partially pregelatinized starches such as Starch 1500 can act simultaneously as a filler, binder, and disintegrant. By replacing several single‑function excipients with one multifunctional option, it is often possible to simplify the formulation and reduce tablet weight, resulting in a smaller, more manageable dosage form that is easier for patients to swallow.
In addition to core formulation changes, the application of a tablet coating can significantly enhance swallowability. Film coatings provide a smoother, glossier surface that reduces friction in the mouth and oesophagus, making tablets easier to swallow compared to uncoated cores.
To optimize dosage forms for patient acceptability, a collaborative development approach that integrates patient feedback, market research, and robust in‑process testing is recommended. Early engagement with patients and caregivers helps identify real‑world challenges related to mouthfeel, taste, and tablet size, ensuring that formulation decisions are guided by user experience rather than technical considerations alone. Market research further supports this process by highlighting population‑specific needs, regional preferences, and competitive benchmarks. These activities enable formulators and manufacturers to design dosage forms that are not only technically robust, but also aligned with patient expectations, ultimately supporting adherence and successful product adoption.
Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are increasingly emphasising the need for accessible, patient‑friendly oral dosage forms. Their guidance (FDA & EMA) encourages manufacturers to consider factors such as tablet and capsule size, shape, coating, and overall ease of swallowing as part of quality‑by‑design and patient safety principles. This regulatory focus mirrors growing market demand for paediatric, geriatric, and dysphagia‑friendly medicines, where conventional tablets may present adherence challenges.
Tablet coatings aren’t just for stability; they can improve mouthfeel and other properties that make it easier to swallow. By optimising tablet size and shape, leveraging proven coating technologies, and addressing sensory experience from the first interaction, manufacturers can remove a critical barrier to adherence and acceptance. When these design choices are informed by patient insight and aligned with regulatory expectations, they do more than improve usability—they strengthen brand reputation, reduce non‑adherence risk, and support long‑term commercial success. In an increasingly competitive market, designing tablets that are easier to swallow is not just good science; it’s a clear strategic advantage.
Colorcon has many years of experience supporting the pharmaceutical and nutraceutical industry with tablet design. Tools like photo-realistic images and 3D printed tablet models can help development and marketing teams visualize options and aid market research studies. Contact Colorcon for more information.
What Types of Coatings of Coatings Are Used in the Pharma Industry?
Pharmaceutical Formulations for Older Patients (Pages 97-128)