Developing user friendly dosage formats for people experiencing difficulties swallowing
Developing user friendly dosage formats for people experiencing difficulties swallowing
In the past few decades, there has been significant growth in the number of formats available in the market for over-the counter (OTC) and nutritional products. Healthcare companies seek to provide product differentiation by targeting specific consumer preferences, such as convenience, ease of use and flavour preferences, but not much focus has been given to specific conditions like difficulty swallowing or dysphagia.
Trouble swallowing is most common in elderly people. Conservative estimates suggest that it may be as high as 22% in adults over 50 years of age¹. For children, is estimated that only 1% in the general population² has swallowing difficulties; however, even mild cases can have a detrimental effect on dietary intake and thus, growth and development.
In the OTC and nutritionals market, oral dosage formats like tablets and capsules are among the most used by consumers³ (Fig. 1), mostly because of their simplicity and, in some cases, cost efficiency. However, many people experience difficulties swallowing them. This results in poor regimen adherence and negative safety and efficacy consequences⁴.
Symptoms and causes of dysphagia
Difficulties swallowing can be attributed to behavioural or psychological issues such as anxiety⁵ and attitudes towards the characteristics of the product such as size, shape or texture⁶.
Swallowing is a complex process that requires more than 30 nerves and muscles (Fig. 2). Depending on the location of the bolus, the swallowing process is divided in three stages: oral, pharyngeal and esophageal⁷.
People suffering from dysphagia may have functional or structural deficits in the oral cavity, pharynx, larynx or esophagus⁷. They describe their experiences as including pills getting stuck in the throat, uncomfortable feelings, a need for repeated swallowing attempts, gagging, choking, coughing while swallowing or vomiting. According to studies, 28% of affected patients have reported being afraid to take tablets or capsules, with 8.7% having fear of suffocating while swallowing tablets or capsules⁸.
Conditions that might affect the ability to swallow include⁹ neurological problems such as Parkinsons or ALS or physical conditions like dry mouth, which can be caused by medicines like antihistamines and antidiarrheals; cancer treatment with chemotherapy affecting the body or radiation exposed to the neck; head strokes causing oral or pharynx muscle dysfunction or tumors, among others.
In order to overcome the discomfort of swallowing pills, some people choose to modify their dosage formats to facilitate swallowing. Modifications include the splitting or crushing of tablets and opening of capsules to get smaller pieces of the dosage format as well as mixing them with food or dissolving them in water⁸ (Fig. 3). However, in doing this, there might be adverse consequences, such as altering the drug’s stability or bioavailability, failure to reach the site of action or alterations to the taste of the pill that make it more unpleasant10.
Designing user-friendly dosage formats throughout the product’s sensory life cycle
When designing new dosage formats aimed at consumers who experience difficulties swallowing, the whole sensory life cycle of the product should be considered (Fig. 4). By doing this, user acceptability might be improved by making the intake of the product safe, easy and pleasurable while keeping the active ingredients’ proprieties, such as stability and bioavailability, intact.
Some of the products’ properties that can be modified to improve consumer acceptance include:
General appearance
Colour: From the moment the consumer’s eye meets the supplement, several psychological associations will be made based on its overall appearance. The colour of a product can affect the consumer’s perception of it, depending on the consumer’s gender, culture and age. This has an impact on the acceptability of the product.
Size: If tablets are to be swallowed, the FDA recommends that the largest dimension of a tablet or capsule should not exceed 22 mm11. Some studies even suggest that consumers prefer to take more medium-sized pills than a large pill or tablet6. For dosage formats that are not intended to be swallowed, e.g. chewable tablets, it is important to consider that the size is appropriate for the consumer e.g. smaller tablets for children; and safety issues such as the risk of choking if inadvertently swallowed intact should also be considered.
Shape: Studies suggest that oval formats may be easier to swallow and have faster esophageal transit times than round tablets of the same weight. Compliance with health regimens may be influenced by the size and shape of the tablet or capsule11.
Palatability
Taste: This is one of the most important parameters governing compliance. Taste masking is defined as a perceived reduction of an undesirable taste that would otherwise exist12. Taste masking the active ingredients using sweeteners and flavours can increase acceptance from users. This is especially relevant when developing dosage formats which are not to be swallowed directly, but chewed, sucked or mixed in liquids (e.g. liquids, gummies, chewables, granules/powders, effervescent tablets, etc.) as these will be tasted more intensely. Thanks to advanced taste masking technologies, it is possible to customize specific flavours targeting the user’s preference (culture, age, etc.). Different sensations can be achieved through the addition of flavouring and sweetening agents.
Texture and consistency: If the dosage format is chewed, users tend to desire a smooth texture upon disintegration versus gritty or chalky textures. Some excipients (e.g. sweeteners) can provide a smooth consistency to the liquid remainders in the mouth13. Studies have shown in some cases texture is just as important as flavor, highlighting four main preference categories: chewers, crunchers, smooshers and suckers14. Consumer preferences regarding texture should also be considered by developing dosages form that provide a crunchy, soft or chewy sensation.
Aftertaste: Some ingredients might leave a metallic aftertaste or even a dry mouth sensation that is unpleasant for the user. Several techniques, such as providing a choice of flavours, sweeteners or coatings improve the palatability of the product after it has been ingested.
Conclusion
Developing delivery technologies with consumers in mind
Given the large proportion of the population that experiences difficulties swallowing, together with the growing market for OTC and nutritional products, it is important for the healthcare industry to look into new delivery formats aimed at easing the intake of its products—improving its experience and compliance.
When developing a new product it is important to have a deep understanding of the product type and target consumer preferences. By introducing dosage formats that are according to consumers needs and preferences, it is possible to create a clear competitive differentiation and boost profitability.
Sources: 1. American Speech-Language-hearing Association. “Adult Dysphagia” https://www.asha.org/Practice-Portal/Clinical-Topics/Adult-Dysphagia/. July 2020.
2. Dodrill P, Gosa M, M: Pediatric Dysphagia: Physiology, Assessment, and Management. Ann Nutr Metab 2015;66(suppl 5):24-31. doi: 10.1159/000381372 https://www.karger.com/Article/Fulltext/381372
3. 2019 CRN Consumer Survey on Dietary Supplements: Consumer Intelligence to Enhance Business Outcomes”, 2019.
4. Kerins, M. “Physical / Mechanical hazard: swallowing” April 2020 https://www.youtube.com/watch?v=iwFArs9M57E, July 2020.
5. Doss, Will. “Anxiety’s Overlooked role in swallowing disorders”. Northwesterne Medicine Feinberg School of Medicine. https://news.feinberg.northwestern.edu/2020/02/anxietys-overlooked-role-in-swallowing-disorders/ 2020.
6. Fields, J., Go, J. T., & Schulze, K. S. (2015). Pill Properties that Cause Dysphagia and Treatment Failure. Current therapeutic research, clinical and experimental, 77, 79–82. https://doi.org/10.1016/j.curtheres.2015.08.002
7. Matsuo, K., & Palmer, J. B. (2008). Anatomy and physiology of feeding and swallowing: normal and abnormal. Physical medicine and rehabilitation clinics of North America, 19(4), 691–vii. https://doi.org/10.1016/j.pmr.2008.06.001
8. Schiele JT, Quinzler R, Klimm HD, Pruszydlo MG, Haefeli WE. Difficulties swallowing solid oral dosage forms in a general practice population: prevalence, causes, and relationship to dosage forms.
9. Jackson, Shane. “Optimising medicine administration in patients with swallowing difficulties”. Australian Pharmacist. January 2017. https://www.gloup.eu/files/optimisingmedicine.pdf
10. Royal Pharmaceutical Society. “Pharmaceutical Issues when Crushing, Opening or Spliting Oral Dosage Forms”. June 2011.
11. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Guidance for Industry”. June 2015. https://www.fda.gov/media/87344/download July 2020.
12. Harmik Sohi, Yasmin Sultana & Roop K. Khar (2004) Taste Masking Technologies in Oral Pharmaceuticals: Recent Developments and Approaches, Drug Development and Industrial Pharmacy, 30:5, 429-448
13. Renu, Dahiya, J., Jalwal, P., & Singh, B. (2015). Chewable Tablets: A Comprehensive Review. The Pharma Innovation Journal
14. Chaker, A.M. “Why Food Companies Are Fascinated by the Way We Eat” https://www.wsj.com/articles/why-food-companies-are-fascinated-by-the-way-weeat-1376434311. October 2
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