WEST POINT, Pa., Oct. 11, 2006 (PRIMEZONE) -- A new study that tested the "swallowability" of different forms of tablets and capsules showed patients can more easily take film-coated oval shaped tablets than any other commonly manufactured solid dosage forms.
The 48-patient, open-label, randomized, four-way crossover study was commissioned by Colorcon, Inc., a leading provider of technology and consulting services to the world's pharmaceutical companies. Conducted by Glasgow-based Bio-Images Research Ltd., the study compared the swallowability of uncoated tablets and caplets, and soft and hard gelatin capsules, to film-coated dosages. Researchers used sophisticated nuclear medicine cameras to study medication passage from the mouth to the lower GI tract, and found that oval film-coated tablets demonstrated the fewest instances of slow transit in the esophagus (greater than 15 seconds), fewer incidences of lodging in the esophagus, and the least likelihood of causing swallowing problems.
"The study has important implications for both pharmaceutical manufacturers and patients, especially those who have swallowing difficulty," said Frederick R. Kettinger, General Manager of Colorcon's new Brand Enhancement System for Tablets (BEST(R)) service that helps pharmaceutical companies make their products more patient-friendly and resistant to medication errors.
"The results confirm that film-coating an oval-shaped dosage form improves the ease of swallowing for patients, enabling the dosage to safely and quickly pass through the esophagus, without concern about lodging and mucosal irritation. Coated oval tablets seem most likely to provide greater patient comfort, acceptance and safety, and could also lead to improved compliance, and patient preference for a medication in this form."
Swallowing difficulty is widespread among American adults. Forty percent of people report problems swallowing pills, according to a Harris Interactive Survey. Most describe the sensations as having "a pill stuck in their throat" (80%), having a "bad after taste in their mouth" (48%), or gagging (32%). (1)
Seniors, in particular, have difficulty swallowing pills. Swallowing disorders in elderly Americans are estimated to range between 16% and 22%(2) for ambulatory adults over 55 years old, and 40% or more in nursing homes.(3) According to the National Institutes of Health, between 1 and 4 million Americans - 90% women - suffer from an autoimmune disorder known as Sjogren's Syndrome that destroys their salivary glands, and makes swallowing solid dosage forms especially difficult.
Study Results
Coating. The Colorcon-commissioned study announced today demonstrates that oral dosage form film-coating and shape are key determinants of an oral dosage design in the prevention of esophageal arrest. Coated, oval-shaped tablets did not lodge in the esophagus (0 out of 72 trials), while uncoated oval tablets lodged in the esophagus in 4 out of 23 subjects for a period of 10 minutes. The 10-minute interval was the maximum recordable time for the study to ensure subject safety. After 10 minutes, each subject drank a full glass of water to dislodge the uncoated tablet from the esophagus.
Speed and Disintegration. Owing to the greater surface area which could come in contact with the esophagus, caplets and capsules, as a class of oral dosage forms, had an overall greater incidence of slow transit (25 out of 82 trials) than coated oval tablets (4 out of 72 trials). Each caplet and capsule studied also lodged in the esophagus in at least one subject. Although the majority of oral dosage forms had completely disintegrated at 30 minutes, a significant number of hard gelatin capsules (5 of 24) and soft gelatin capsules (6 of 21) were still intact.
Uncoated tablets tend to become arrested in the esophagus approximately 20% of the time, remaining for potentially greater than 10 minutes. During this time, they can dissolve and release the active ingredient, which can present a patient safety concern. For example, the active of an NSAID would be a mucosal irritant that could cause ulceration of the esophagus upon arrest.
About Swallowing Difficulty
Swallowing disorder (dysphagia) is associated with many medical conditions, including stroke, Parkinson's disease and AIDS. In addition to patients diagnosed with swallowing disorders post-stroke, with Parkinson's disease or sarcopenia, swallowing disorders occur in non-dysphagic patients with abnormal esophageal function identified in 63% of seniors.(4) Swallowing difficulty also occurs when patients drink too little or no water when taking their pills. As a result, many fail to take medication as directed, which can have serious health consequences.
Dysphagia and taking too little water increase the likelihood of oral dosage forms lodging in the esophagus, which can cause problems such as erosive esophagitis. If oral dosage forms stick or reflux back into the gullet, the impaired clearance prolongs contact with the esophageal mucosa, causing irritation, and can lead to ulceration of the esophagus.
Certain medications are commonly associated with pill esophagitis, including nonsteroidal anti-inflammatory drugs (NSAIDs), tetracyclines, quinidine, iron salts, slow-release potassium supplements and bisphosphonates.(5) The main factors that limit esophageal transit are size, shape and surface characteristics of the medication, as well as taking too little water and the position of the body when swallowing.
About the Study
The open-label, randomized, four-way crossover study of 48 healthy volunteers observed the transit of comparable-sized, radio-labeled oral dosage forms using gamma scintigraphy. The oral dosage forms were administered with 30 ml of water. Swallowing and transit times were observed for ten minutes, with images taken every 0.5 seconds for the first 30 seconds and every 15 seconds thereafter, and a static image taken 30 minutes post-dose. The two-part study tested 24 patients in each part. Part A compared capsules and caplets: soft gelatin capsules, hard gelatin capsules, uncoated caplets, and coated caplets. Part B compared oval tablets, using three coated tablets with different levels of gloss in the finish, and an uncoated tablet.
About Colorcon
Colorcon, Inc. is the world leader in developing advanced film-coating systems for solid dosage medications. For more than 45 years, Colorcon has assisted pharmaceutical scientists worldwide with tablet formulation, modified release film coatings, and advanced science expertise, helping them produce distinctive, patient-friendly tablets that are easy to identify and swallow. BEST(R), the Brand Enhancement System for Tablets, is a Colorcon division that provides marketing and technical expertise enabling pharmaceutical companies to distinguish their tablets through color, shape, high-definition imprinting, special coatings, flavors, and product security identifiers. The resulting tablets are designed to improve compliance and reduce medical error, benefiting patients, pharmacists and the health care industry alike. For more information about Colorcon and BEST(R), please visit http://www.colorcon.com/best.
Footnotes
1. "Pill-Swallowing Problems in America," Harris Interactive Survey
(June 2003).
2. Hind JA, et al (2001) Arch Phys Med Rehabil. 82:1661-5.
3. Siebens H, et al. (1986) J Am Ger. Soc. 34:192-198.
4. Ekberg O & Fineberg MJ (1991) AJR 156:1181-1186.
5. Kahrilas, PJ., Howden CW. Contemporary Diagnosis and Management of
Dyspepsia and GERD. (2002) Handbooks in Healthcare Co. p.22.