Abstract
Meloxicam is one of oxicams anti-inflamatory drugs that are effective to relieve toothaches, arthritis, dysmenorrhea, and fever. Meloxicam in this study was milled with High Energy Milling (HEM) method to obtain its nano size and then direct compression method was used to produce Orally Disintegrating Tablet (ODT). ODT is designed to be rapidly dissolved on the tongue within a minute. It can be administered without water or chewing and may improve the bioavailability and effectiveness of the drug, and increase the patient’s adherence. The present study aimed to understand the effects of Ac-Di-Sol and Kollidon CL as superdisintegrants, that were used separately or in combination, on the characteristics of nanoparticles meloxicam ODT. It was also to obtain the best proportion of combination between Ac-Di-Sol and Kollidon CL that can produce the optimum formula of meloxicam ODT. The effects of single or combined superdisintegrants were evaluated using Simplex Lattice Design (SLD). Ac-Di-Sol (X 1 ) and Kollidon CL (X 2 ) were the independent variables, while the dependent variables were friability (Y 1 ), disintegrating time (Y 2 ), wetting time (Y 3 ), and percent meloxicam release after 60 seconds (Y 4 ). Optimization of five nanoparticle meloxicam ODT formulas was conducted using Design Expert 7.1.5. The combination of Ac-Di-Sol 4.05mg (X 1 ) and Kollidon CL 10.95mg (X 2 ) in 150mg nanoparticles meloxicam ODT can produce optimal ODT characteristics. After verification there was no difference between predicted value and observed value with p value > 0.05.
Highlights
Tablet is a solid dosage form convenience to carry, having a controllable duration of action
Milling was performed to decrease the particle size of meloxicam until it reached < 1μm. This may improve the solubility of meloxicam as it would be formulated to become rapid dissolving tablet
Measured by Particle Size Analyzer (DelsaTM Nano, Beckmann Coulter), milled meloxicam powder showed particle size reduction from 4057.4nm to 372.6nm with polydispersity index of 0.295 (Figure 1). This proves that milling can reduce the particle size of meloxicam and it can be expected that solubility, bioavailability, and the onset of action of meloxicam will be more rapid to relieve pains due to arthritis or rheumatic diseases, for instances
Summary
Tablet is a solid dosage form convenience to carry, having a controllable duration of action. The primary criterion of ODT is rapid dissolution or disintegration inside the mouth, ODT should be formulated by direct compression method and contained high concentration of superdisintegrant. Meloxicam was used as the active component of ODT in this research. It is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclo-oxygenase 2 (COX-2) and is used in the treatment of osteoarthritis and rheumatoid arthritis (Mahrouk et al, 2009). The particles yielded from milling were formulated to become ODT, which was characterized using several tests including weight variation, uniformity of tablet content, hardness, friability, disintegrating time, wetting time, and in vitro dissolution. The optimum formula would be verified and analyzed using OpenStat software
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