Formulation and Evaluation of Mouth Dissolving Film (MDFs) Containing Active Pharmaceutical Ingredient (API)

Ondansetron is one of the medications most commonly used for the empiric treatment of nausea and vomiting. Ondansetron has excellent utility as an antiemetic drug, and it is effective against nausea and vomiting of various etiologies. Common uses of ondansetron include the prevention of chemotherapy-induced and radiation-induced nausea and vomiting, the prevention of postoperative nausea and vomiting, and off-label use for the prevention of nausea and vomiting associated with pregnancy. However, it is not effective for motion sickness-induced nausea.  This activity will cover the mechanism of action, pharmacology, adverse event profiles, eligible patient populations, contraindications, and monitoring. It also highlights the interprofessional team's role in managing patients needing ondansetron therapy [1-5]. The study aims to create and test oral dispersible tablets of ondansetron hydrochloride using a direct compression method and investigate the impact of a natural disintegrant, Albizia lebbeck seeds, on the tablets' disintegration characteristics. The objectives include extracting the superdisintegrant, designing fast dissolving tablets with different fenugreek seed extract concentrations, optimizing formulation parameters, assessing physical characteristics, evaluating disintegration time in simulated saliva, conducting dissolution studies to determine the release profile, and ensuring tablet stability under different storage conditions.

2. Materials And Methods

2.1 Preformulation Studies

The study focuses on the characterization and identification of Gliclazide, a proton pump inhibitor, for its potential therapeutic benefits in treating gastric acid-related disorders. The drug samples were examined for appearance, color, and odor. The melting point of Gliclazide was determined using the capillary method, where a fine powder of the drug was filled in a glass capillary tube and dipped in liquid paraffin (6-8).

2.2 Pre Compression Study

Key parameters evaluated during pre-compression include bulk density, tapped density, Hausner's ratio, and Carr's index, which provide insights into the flow properties and compressibility of the powder blend. Moisture content and particle size distribution also play a significant role in determining the stability and release profile of omeprazole within floating matrices (9-11).

2.3 Formulation and Optimization of Ondansetron HCI Dispersible Tablets by using Direct Compression Method

Ondansetron HCI dispersible tablets were prepared by direct compression method according to the formula (Table 1). A total number of four formulations (F1 to F5) of 50 mg Ondansetron HCI dispersible tablets were prepared using 1 natural superdisintegrants gum obtained from Albizia lebbeck seeds (ALG) with 5 different concentrations. All the ingredients were passed through mesh no 60 separately and collected. The drug, aspartame and microcrystalline cellulose were mixed uniformly with gentle triturating using mortar and pestle to get a uniform mixture. Required quantity of superdisintegrants and aspartame were taken for each specified formulation and mixed with the above mixture (12, 13).

Table 1: Formulation Design of Ondansetron HCI Fast Dissolving Tablets

2.4 Post Compression Evaluation

The study focuses on factors such as hardness, friability, disintegration time, and drug release study and stability studies. Understanding these characteristics is crucial for optimizing tablet performance and ensuring effective therapeutic outcomes. Factors like particle size distribution and moisture content also impact these evaluations. Comprehensive postcompression evaluations are essential for developing effective floating tablets that meet pharmacological standards (14-16).

3. RESULTS AND DISCUSSION

3.1 Preformulation Studies

Organoleptic characterization, melting point determination, and solubility check are essential techniques in the field of pharmaceutical sciences. These methods provide valuable information about the physical and chemical properties of drugs, which are crucial for their formulation and efficacy. Organoleptic characterization involves the sensory evaluation of a drug using our five senses – sight, smell, taste, touch, and hearing. This method helps in identifying any physical changes such as discoloration, odor, or taste alterations that may occur during storage or handling (Table 2). The Indian pharmacopeia recommended the capillary method for melting point determination, and the standard melting point of drug was found to be 177.36°C, within the reported range of 175–179°C, indicating the drug sample's purity. Solubility check is also a key parameter in drug development as it determines the ability of a drug to dissolve in various solvents. This information is crucial for designing dosage forms that ensure optimal absorption and bioavailability of the drug (Table 3).

Table 2: Identification and Characterization of Drug

Table 3: Solubility Study of Ondansetron HCI

3.2 Evaluation Parameters:

3.2.1 Precompression Evaluation of powder blended characteristics of tablet formulation

The optimal drug release kinetics in tablet formulations are influenced by factors such as particle size distribution, flow properties, blend uniformity, and compressibility. A narrow particle size distribution ensures uniform blending and prevents segregation during compression, resulting in a more consistent drug release profile. Poor flow properties can lead to uneven distribution of active ingredients, causing variability in drug release rates (Table 4).

Table 4: Precompression Evaluation of Powdered Blend

3.2.2 Postcompression Evaluation of powder blended characteristics of tablet formulation

Postcompression evaluation is a crucial process in determining the quality and performance of tablet formulations. It involves assessing parameters like hardness, friability, disintegration time, and drug release profile to determine the tablet's performance. Hardness measures the mechanical strength of a tablet, while friability measures its tendency to break or chip under stress. A low friability value indicates good tablet integrity. Disintegration time determines the rate and extent of drug release, which directly impacts the therapeutic efficacy of a tablet formulation. The drug release profile is the most crucial parameter in postcompression evaluation, as it directly impacts the therapeutic efficacy of a tablet formulation (Table 5).

Table 5: Postcompression Evaluation of Tablet formulation