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Acetaminophen-containing chewable tablets with suppressed bitterness and improved oral feeling
Hiroyuki Suzuki1, Hiraku Onishi, Seiji Hisamatsu
1Department of Drug Delivery Research, Hoshi University, 2-4-41, Ebara, Shinagawa-ku, Tokyo 142-8501, Japan.
International Journal of Pharmaceutics
|May 26, 2004
Summary
Researchers developed improved acetaminophen chewable tablets by using specific hard fats and sweetening agents to mask bitterness and enhance taste. The best formulation utilized Witocan H with saccharin and Benecoat BMI-40 for optimal drug release and palatability.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Formulation Science
Background:
- Acetaminophen (APAP) is a widely used analgesic and antipyretic.
- Chewable tablets require palatable formulations to improve patient compliance, especially for pediatric use.
- Masking the bitter taste of active pharmaceutical ingredients like acetaminophen is a significant formulation challenge.
Purpose of the Study:
- To develop palatable acetaminophen chewable tablets with suppressed bitterness and improved oral sensation.
- To evaluate the suitability of various hard fats as matrix bases and sweetening agents as taste-modifying corrigents.
- To optimize the formulation for desirable drug release characteristics and sensory attributes.
Main Methods:
- Screening of hard fats (Witepsol, Witocan series) for matrix base properties.
- Evaluation of various sweetening agents (sucrose, xylitol, saccharin, aspartame, sucralose) and excipients (Benecoat BMI-40, cocoa powder) for taste masking.
- Formulation of chewable tablets using selected excipients and acetaminophen.
- Assessment of melting characteristics, drug release rates, bitterness suppression, and overall oral feeling.
Main Results:
- Witocan H and Witocan 42/44 were selected for their favorable oral feeling.
- Mixtures of Witocan H/Witocan 42/44 demonstrated drug release dependent on ratio, with 92.5% (w/w) and higher showing good release.
- A formulation combining Witocan H with 1% (w/w) saccharin and 5% (w/w) Benecoat BMI-40 (Sc1-B5) exhibited excellent bitterness suppression and good drug release.
- Another formulation using a Witocan H/Witocan 42/44 mixture with aspartame and Benecoat BMI-40 also showed good taste masking but inferior drug release compared to Sc1-B5.
Conclusions:
- The Witocan H tablet formulation (Sc1-B5) is proposed as an optimal acetaminophen chewable tablet.
- This formulation effectively suppresses bitterness, offers low sweetness, improves oral feeling, and ensures good drug release.
- The study highlights the potential of specific hard fat combinations and sweetening agent-excipient systems in developing palatable oral dosage forms.