Palestinian Medical and Pharmaceutical Journal (Pal. Med. Pharm. J.)

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Keywords

• Tablets
• Time;
• Disintegration
• Sodium;
• Taste
• Ibuprofen;
• Wet
• Orodispersible
• Croscarmellose
• Paracetamol;
• (ODTs);
• Masking.
• Granulation;

Abstract

Background: Orodispersible tablets (ODTs) are an effective alternative to traditional oral medications, especially for individuals who have difficulty swallowing, such as children, the elderly, and patients with certain medical conditions. These tablets dissolve quickly in the mouth without the need for water, enhancing both convenience and treatment compliance. However, developing ODTs presents several challenges, including poor tablet strength, fragility, and an often-unpleasant taste. Aims: This study set out to formulate and assess an optimized ODT that combines paracetamol and ibuprofen for fast and effective relief from pain and inflammation. The objective was to achieve quick disintegration, adequate mechanical strength, and improved taste, while ensuring the final product meets pharmacopeial quality standards. Methods: A total of seventeen formulations (F1–F17) were developed using both direct compression and wet granulation techniques. Various concentrations of croscarmellose sodium (as a superdisintegrant), polyvinylpyrrolidone (as a binder), and different flavoring agents were tested. Each formulation was evaluated based on pre-compression flow properties, particle size, and post-compression quality parameters such as disintegration time, drug release profile (using UV spectrophotometry), hardness, friability, and taste. Results: Tablets prepared using direct compression showed rapid disintegration but lacked structural integrity and had an unpleasant taste. Switching to wet granulation significantly improved tablet strength, consistency, and flavor. The final optimized formulation (F17), which included 41.7% paracetamol, 33.3% ibuprofen, 2% croscarmellose sodium, and raspberry flavoring, passed all key quality tests. Tablets disintegrated within 3 minutes, complying with the European Pharmacopoeia criterion for ODTs, had a friability of ~1%, and released more than 90% of the drug content within 10 minutes. Raspberry flavoring effectively masked the bitterness of the active ingredients. Conclusion: The study demonstrates that wet granulation, when combined with carefully selected excipients and effective flavoring, can produce a high-quality, fast-acting orodispersible tablet. The optimized F17 formulation shows strong potential for improving medication adherence and therapeutic outcomes, especially in patients who struggle with swallowing conventional tablets.

معلومات المقال

قيد النشر

الكلمات الإفتتاحية

• Tablets
• Time;
• Disintegration
• Sodium;
• Taste
• Ibuprofen;
• Wet
• Orodispersible
• Croscarmellose
• Paracetamol;
• (ODTs);
• Masking.
• Granulation;

الملخص

Background: Orodispersible tablets (ODTs) are an effective alternative to traditional oral medications, especially for individuals who have difficulty swallowing, such as children, the elderly, and patients with certain medical conditions. These tablets dissolve quickly in the mouth without the need for water, enhancing both convenience and treatment compliance. However, developing ODTs presents several challenges, including poor tablet strength, fragility, and an often-unpleasant taste. Aims: This study set out to formulate and assess an optimized ODT that combines paracetamol and ibuprofen for fast and effective relief from pain and inflammation. The objective was to achieve quick disintegration, adequate mechanical strength, and improved taste, while ensuring the final product meets pharmacopeial quality standards. Methods: A total of seventeen formulations (F1–F17) were developed using both direct compression and wet granulation techniques. Various concentrations of croscarmellose sodium (as a superdisintegrant), polyvinylpyrrolidone (as a binder), and different flavoring agents were tested. Each formulation was evaluated based on pre-compression flow properties, particle size, and post-compression quality parameters such as disintegration time, drug release profile (using UV spectrophotometry), hardness, friability, and taste. Results: Tablets prepared using direct compression showed rapid disintegration but lacked structural integrity and had an unpleasant taste. Switching to wet granulation significantly improved tablet strength, consistency, and flavor. The final optimized formulation (F17), which included 41.7% paracetamol, 33.3% ibuprofen, 2% croscarmellose sodium, and raspberry flavoring, passed all key quality tests. Tablets disintegrated within 3 minutes, complying with the European Pharmacopoeia criterion for ODTs, had a friability of ~1%, and released more than 90% of the drug content within 10 minutes. Raspberry flavoring effectively masked the bitterness of the active ingredients. Conclusion: The study demonstrates that wet granulation, when combined with carefully selected excipients and effective flavoring, can produce a high-quality, fast-acting orodispersible tablet. The optimized F17 formulation shows strong potential for improving medication adherence and therapeutic outcomes, especially in patients who struggle with swallowing conventional tablets.