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Oral sustained-release suspension based on a lauryl sulfate salt/complex
Yuuki Kasashima1, Shinya Uchida2, Keiichi Yoshihara3
1Pharmaceutical and Technology Labs, Astellas Pharma Inc., 180 Ozumi, Yaizu, Shizuoka 425-0072, Japan; Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan.
International Journal of Pharmaceutics
|October 22, 2016
Summary
Lauryl sulfate (LS) salt/complex shows promise as a novel oral drug delivery system. This formulation enables sustained drug release over a wide pH range, improving oral suspension efficacy and patient compliance.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Materials Science
Background:
- Mirabegron exhibits pH-dependent solubility, posing challenges for oral sustained-release formulations.
- Developing novel carriers is crucial for improving drug solubility and release profiles.
Purpose of the Study:
- To assess the feasibility of using lauryl sulfate (LS) salt/complex as a novel carrier for oral sustained-release suspensions.
- To formulate and characterize microparticles containing LS salt/complex for enhanced drug delivery.
Main Methods:
- Formulation of LS salt/complex with mirabegron.
- Preparation of microparticles via spray drying using ethylcellulose (Aquacoat® ECD).
- In vitro dissolution studies and in vivo pharmacokinetic evaluation in dogs.
Main Results:
- LS salt/complex significantly reduced mirabegron solubility, enabling sustained release across various pH conditions.
- Spray-dried microparticles (<200μm) exhibited controlled dissolution, tunable by Aquacoat® ECD concentration.
- The suspension demonstrated stability and sustained-release properties in vivo, with a reduced Cmax.
Conclusions:
- Microparticles incorporating LS salt/complex represent a viable strategy for developing oral sustained-release suspensions.
- This novel approach offers potential for improved therapeutic outcomes and reduced side effects for drugs like mirabegron.