[Development of a novel oral jelly formulation for elderly patients].
Deterioration of the swallowing function in elderly persons and drug refusal among the behavioral abnormalities in Alzheimer's disease (AD) are commonly reported. Therefore, we developed an easy-to-swallow jelly formulation of Donepezil HCl which AD patients can take as a dessert. The development process, however, was full of trade-off problems. (1) Need for evaluating the taste of a drug product vs. Safety of human sensory evaluation of the taste. The trade-off was resolved by using a taste sensor. (2) Speed of development vs. Safety of the manufacturing process. We put priority on the safety rather than speed, and a safer antioxidant agent was found. (3) Usability of the container for AD patients with dysphagia vs. Size of the container. We put priority on its being user-friendly rather than on the size and chose a stable wide-mouth cup. (4) Suitable texture of jelly for swallowing the drug product vs. Residual volume of jelly in the cup. We designed the texture so that the residual volume of jelly in the cup was reduced. (5) Easy peeling properties of aluminum seal vs. High sealing strength for sterilization. The sealing strength was adjusted so that it was adequate to sterilize the drug product. (6) One cup in a heat-sealed aluminum pillow package to prevent overdose vs. Seven cups in a pillow package. A single-dose package was relatively expensive, but it was chosen to assure safety. We faced many difficult trade-off problems in the development of process. However, they were resolved using technical innovations and a people-friendly policy. Finally, we were able to launch a novel oral jelly formulation for elderly patients.
Planning & Operation Section, Customer Joy Department, Eisai Japan, Eisai Co., Ltd.
Tsutomu
T
Harada
Koichi
K
Yasuoka
Maho
M
Sakurai
Tsukasa
T
Murase
Takayuki
T
Owaki
D000284:Administration, Oral; D000368:Aged; D003680:Deglutition Disorders / Q000503:physiopathology; D015195:Drug Design; D004349:Drug Packaging; D004355:Drug Stability; D005782:Gels; D006801:Humans; D013649:Taste
D005782:Gels