Tablets & Capsules


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eye on Physiological changes in elderly patients can lead to numerous chal- lenges. For instance, it's common for their total body fat to increase while total body water decreases, and the change in their fat-to-water ratio can affect the distribution of hydrophilic and lipophilic active pharmaceutical ingredients (APIs). Other common changes include higher gastric pH, less hepatic mass and blood flow, reduced kidney function, altered plasma protein binding, and reduced drug metabolism. Stegemann and Reo noted that those changes can lead to serious adverse drug reactions [1]. The authors also noted that approximately 35 percent of poly - pharmacy patients experienced ad - verse drug reactions, and that: • Upon review, 95 percent of the adverse reactions were predictable; • 63 percent of patients required a physician; • 10 percent required emergency room treatment; and • 11 percent required hospitalization. In short, these outcomes required expensive intervention. Yet despite its special needs, the geriatric population is not normally considered in clinical trials. More often, they focus on younger adults and now, increasingly, the pediatric population. What can be done for the elderly: The challenge of dose administration To be considered elderly, a patient is usually 65 or more years old, but the definition can and should be extended downward to 55+ years, given that long-term care environ- ments are not just for the elderly. Conditions such as Parkinson's dis- ease, for example, are frequent in people younger than 50. That disease is also associated with difficulty in swallowing. As with very young patients, the elderly often require care-givers to administer or help them self-adminis- ter drug products. But unlike chil- dren, the elderly often must self- medicate, and that leads to challenges in packaging and identify- ing drug products to make adminis- tration as easy and accurate as possi- ble. Even when tablets and capsules are removed from their original pack- aging and organized in a Sunday-to- Saturday holder, the patient may still need to differentiate a white caplet from a white capsule. For many elderly patients, that's not easy. Most pharmaceutical manufactur- ers default to the tablet form when possible, and most offer two or three dose strengths. Some tablets are also scored so they can be split to reduce dose strength further if required. When patients have difficulty swal- lowing a tablet, they or their care- giver often resort to crushing the tablet or opening the capsule and sprinkling the contents into a drink or food. Solid dosage forms are also sometimes added to an enteral feed- ing tube. The implications of such actions have been addressed else- where. They are considerable and should be addressed by formulators, brand managers, and business devel- opment professionals involved in drug delivery. Tablets & Capsules March 2014 41 Alen Guy IMCD Group excipients This article discusses the role that excipi- ents and dosage forms can play in addressing the challenges of treating geri- atric patients. We're all getting older, of course, but worldwide the percentage of people aged 65 and older will grow from 528 million in 2010 to about 1.47 billion in 2050 [1]. Furthermore, people in that age cohort, who now use 30 to 50 percent of prescriptions, will use 60 to 90 percent of them by 2050 [1]. That makes sense when you consider that someone 55 years old has, on average, 2.68 chronic con- ditions [2]. By the time this person is older than 65, the average reaches 5 chronic conditions [3]. In addition, nearly 40 percent of the elderly suffer from arthritis and another serious health condition, such as cardiovascu- lar disease or diabetes [4]. The elderly also face cognitive, visual, motor, and swallowing limita- tions, and likely consume numerous drug products, known as polyphar- macy. Of the approximately 40 per- cent of American adults who have experienced difficulty swallowing tablets or capsules, the vast majority are the elderly [5]. It has been estimated that 35 to 68 percent of the elderly have some degree of swallowing dysfunction, including dysphagia [6, 7]. In one sur- vey of patients and care-givers in England, 477 patients reported diffi- culty. Of those, 68 percent opened the capsule or crushed the tablet, and 64 percent simply didn't take their medicine as prescribed if it was too difficult to swallow [8]. l-EOE_40-45_Masters 3/5/14 10:33 AM Page 41

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