RAPID DISSOLUTION: DEVELOPMENT AND ASSESSMENT OF A NOVEL DRUG FORMULATION

Аннотация

INTRODUCTION difficulty swallowing tablets or capsules, such as Fast-dissolving drugs have become increasingly pediatric, geriatric, and dysphagic patients. popular due to their convenience and ease of However, the development and formulation of fast- administration, particularly for patients who have dissolving drugs present significant challenges, difficulty swallowing or require rapid onset of particularly with regard to maintaining stability, action. However, the development and formulation efficacy, and safety despite the accelerated of such drugs can be challenging as they need to dissolution rate. maintain their stability and efficacy despite the accelerated dissolution rate. In this study, we Various techniques have been employed to develop aimed to formulate and develop a fast-dissolving fast-dissolving drugs, including lyophilization, drug using a novel approach and evaluate its direct compression, and spray-drying. These properties and performance. Fast-dissolving drugs techniques often involve the use of have gained significant attention in recent years superdisintegrants, which are excipients that due to their numerous advantages, including ease enhance the dissolution rate of the drug and of administration, improved patient compliance, promote rapid disintegration of the tablet or and rapid onset of action. These drugs are capsule in the oral cavity. However, the choice of particularly beneficial for patients who have excipients and the formulation approach can https://www.theamericanjournals.com/index.php/tajmspr 1 THE USA JOURNALS THE AMERICAN JOURNAL OF MEDICAL SCIENCES AND PHARMACEUTICAL RESEARCH (ISSN – 2689-1026) VOLUME 06 ISSUE05 significantly affect the properties and performance cellulose, which were chosen based on their ability of the fast-dissolving drug. to achieve the desired properties of the drug. We tested various formulations and optimized the METHODS composition based on the disintegration time and We used a combination of direct compression and dissolution rate. We also evaluated the taste of the freeze-drying techniques to formulate and develop drug using a panel of human volunteers. Finally, we a fast-dissolving drug. The excipients used included conducted stability testing to ensure the drug mannitol, crospovidone, and microcrystalline remained effective and stable over time. A. Formulation Excipient selection: Mannitol, crospovidone, and microcrystalline cellulose were selected as https://www.theamericanjournals.com/index.php/tajmspr 2 THE USA JOURNALS THE AMERICAN JOURNAL OF MEDICAL SCIENCES AND PHARMACEUTICAL RESEARCH (ISSN – 2689-1026) VOLUME 06 ISSUE05 excipients based on their ability to achieve the were developed using different ratios of the desired properties of the fast-dissolving drug. selected excipients. The formulations were prepared by direct compression and freeze-drying Preformulation studies: Preformulation studies techniques. were conducted to determine the compatibility of the drug with the selected excipients, as well as to Optimization: The formulations were optimized assess the flow properties of the formulation. based on the disintegration time and dissolution rate. Formulation development: Various formulations B. Evaluation Dissolution rate: The dissolution rate of the optimized formulation was measured using the Disintegration time: The disintegration time of the USP dissolution test. optimized formulation was measured using the USP disintegration test. https://www.theamericanjournals.com/index.php/tajmspr 3 THE USA JOURNALS THE AMERICAN JOURNAL OF MEDICAL SCIENCES AND PHARMACEUTICAL RESEARCH (ISSN – 2689-1026) VOLUME 06 ISSUE05 physical properties, and pharmacokinetic profile. Taste evaluation: A panel of human volunteers Dissolution studies revealed rapid dissolution evaluated the taste of the drug using a 5-point kinetics, with the formulation exhibiting a high hedonic scale. percentage of drug release within a short time Stability testing: The stability of the drug was frame. The optimized composition and formulation evaluated by storing the optimized formulation at techniques resulted in a uniform and homogenous different temperatures and humidity conditions for product with desirable physical attributes, such as 12 months. The drug was tested at various time appropriate hardness, friability, and disintegration points for potency, disintegration time, and time. Pharmacokinetic studies demonstrated dissolution rate. enhanced drug absorption and bioavailability C. Statistical analysis compared to conventional dosage forms, indicating the potential for improved therapeutic outcomes. Statistical analysis was performed using ANOVA and Tukey's test to compare the disintegration DISCUSSION time and dissolution rate of the different The rapid dissolution observed in the developed formulations. A p-value of less than 0.05 was formulation can be attributed to several factors, considered significant. including the selection of suitable excipients, RES