Current challenges and regulatory control over formulation and process variables of pharmaceutical gummies using QbD approach

Abstract Recent advancements in drug delivery highlight the oral route as a convenient and preferred method for drug administration, enhancing therapeutic benefits and improving patient compliance. gummies are particularly appealing to children with full dentition, as they enjoy the taste and texture, often enhanced by fruit juices and extracts. For patients with dysphagia, liquid formulations can pose challenges due to high viscosity, leading to discomfort. To address this, oral medicated gummies have emerged as a novel pharmaceutical preparation, designed to improve safety and efficacy. These formulations are particularly suitable for patients with swallowing difficulties, including paediatric and geriatric populations, making them more compliant than traditional dosage forms. This review aims to discuss the advantages and disadvantages of oral medicated gummies , including gelling agents, excipients, preparation methods, evaluation parameters, and their significance compared to conventional drug forms. [1]Despite significant advancements in drug delivery, the oral route remains the most preferred method for administering medications due to its low treatment costs, ease of use, and high patient compliance. It is considered one of the safest and most cost-effective techniques for drug delivery. Patients generally find oral medications comfortable, as this method is non- invasive compared to parenteral routes. Approximately 80% of all therapeutic agents are delivered orally. Among the various dosage forms, tablets, capsules, and granules continue to be the most favoured. Therefore, it is crucial to advance oral drug delivery technologies to meet patient needs and ensure safe and effective treatments. Oral dosage forms dominate the drug delivery market due to their numerous advantages, including safety, efficacy, cost- effectiveness, and high patient compliance compared to other routes. Among different pharmaceutical dosage forms, oral formulations exhibit the most desirable characteristics of ideal dosage forms.