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논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 저널정보
- 한국약제학회 Journal of Pharmaceutical Investigation Journal of Pharmaceutical Investigation 제52권 제5호
- 발행연도
- 2022.9
- 수록면
- 623 - 638 (16page)
- DOI
- 10.1007/s40005-022-00582-y
이용수
초록· 키워드
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Purpose The purpose of this study was to develop a patient-centric formulation of tegoprazan, a novel potassium-competitive acid blocker, using modified-release drug-coated pellets.
Methods Tegoprazan tablets, sustained-release (SR) polymer-coated pellets, SR drug-coated pellets, enteric-coated (DR) pellets, SR polymer-coated pellets with an enteric coating (CR1), SR drug-coated pellets with an enteric coating (CR2), and tegoprazan immediate-release (IR) powder were prepared. Dual-release capsules were prepared by combining the IR powder with the CR1, CR2, and DR pellets (IR/CR1, IR/CR2, and IR/DR, respectively). In vitro dissolution tests were conducted to screen the formulations, and in vivo pharmacokinetic (PK) analysis was conducted using cynomolgus monkeys. Design of experiments was employed to optimize the formulation for the CR2 pellets. The effect of the particle size on the dissolution profile of the CR2 pellets was investigated using scanning electron microscopy.
Results In vitro dissolution of the IR/CR1 capsule produced the desired pH- and time-dependent release profile, and in vivo PK analysis confirmed that drug absorption was well-controlled by this formulation. The IR/CR2 capsule exhibited a pHand time-dependent release of tegoprazan that was similar to that of the IR/CR1 capsule. Small drug particles appeared to become embedded in the densely packed coating, thus dissolving more slowly than the medium and large drug particles.
Conclusion Unlike the CR1 pellets, the CR2 pellets did not require an additional coating and curing process. The developed IR/CR2 capsule is also expected to prevent nocturnal acid breakthrough and thus improve patient compliance.
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