Review on Formulation Development of Buccal Tablet

Abstract

By ensuring quality, safety, and effectiveness, formulation development is a crucial component of pharmaceutical development and is necessary for the product\'s therapeutic and commercial success. By bypassing the GIT and hepatic first pass impact, the buccal mode of administration offers numerous benefits, including increased patient compliance. Hardness, weight uniformity, thickness, friability, swelling index, mucoadhesive strength, surface pH, drug-excipient interaction studies, and drug content uniformity were among the metrics used to describe buccal tablets. For both systemic absorption and local administration in the oral cavity, the constant production of saliva and its subsequent swallowing might result in significant drug depletion from the dosage form and, consequently, limited bioavailability. In order to avoid the mentioned drawbacks of traditional oral dosage forms (i.e., tablets, capsules, syrups, etc.), new transmucosal routes such as nasal, rectal, vaginal, ocular, and oral mucosae are being explored as potential substitutes for current oral drug delivery methods. One of the target areas for administering medications in a wide range of dose forms is the buccal oral mucosa, especially for medications intended for systemic absorption and local distribution in the oral cavity.

Introduction

Formulation development is a critical part of pharmaceutical product creation, influencing the product’s lifespan, patentability, and commercial success. It involves combining active drugs with excipients to create the optimal dosage form and manufacturing process, ensuring quality, safety, and efficacy.

The buccal drug delivery system offers an alternative to oral administration by placing medication between the cheek and gums, allowing absorption through the buccal mucosa directly into systemic circulation. This route avoids the drawbacks of oral delivery, such as hepatic first-pass metabolism and degradation in the gastrointestinal tract.

The buccal mucosa consists of multiple layers, including a non-keratinized stratified squamous epithelium, lamina propria, and submucosa, which support drug absorption. Drugs permeate the mucosa via two main pathways: transcellular (through cells) and paracellular (between cells).

Ideal buccal drug delivery systems require properties such as good solubility, strong adhesion, stability at buccal pH, non-toxicity, and appropriate molecular weight. Benefits include enhanced bioavailability, ease of administration, rapid absorption, and avoidance of enzyme metabolism. However, limitations involve restricted dosage amounts, sensitivity to salivation, and limited absorption area.

Common buccal formulations include tablets, patches, films, hydrogels, sprays, and wafers, with buccal tablets being the most popular. These tablets adhere to the mucosa and release drugs either quickly or slowly to improve bioavailability.

Formulation of buccal tablets involves selecting water-soluble, low molecular weight drugs with low first-pass metabolism, along with excipients such as fillers, disintegrants, lubricants, flavoring agents, and sweeteners to optimize drug release and patient compliance.

Conclusion

1) Buccal administration is a topical method of drug delivery that allows medications to diffuse through the oral mucosa, or the tissues lining the mouth, and enter the circulation straight. 2) Generally speaking, buccal administration increases a drug\'s bioavailability and speeds up its beginning of effect. 3) Buccal drug delivery offers several advantages, such as ease of administration, accessibility and withdrawal, retentivity, high patient compliance, low enzymatic activity, and the ability to prevent first-pass metabolism in the liver and pre-systemically occurring clearance in the GIT. 4) It can also be used to prevent first-pass metabolism in the liver and pre-systemically occurring clearance in the GIT. 5) With the right dosage form designs and formulations, permeability in the locally appearing environment of the mucosal layer can be controlled and modified to accommodate drug absorption. 6) Because of its effectiveness, advantages, and ease of access for drug administration through oral mucosal tissue, the buccal route offers a variety of formulation techniques and favorable potential.

References

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Copyright

Copyright © 2025 Ms. Tejasvi Virkar, Mr. Nitin Gawai, Ms. Shivani Aher, Ms. Swamini Debare, Mr. Anmol Adsul. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.