An Overview and in vitro Evaluation of Effervescent Tablets of Lornoxicam with Antacids

468 Available online at www.derpharmachemica.com ISSN 0975-413X CODEN (USA): PCHHAX Der Pharma Chemica, 2025, 17(2): 638-642 (http://www.derpharmachemica.com/archive.html) An Overview and in vitro Evaluation of Effervescent Tablets of Lornoxicam with Antacids Aishwarya Hiremath* Department of Pharmaceutics, Rajiv Gandhi University of Health Sciences, Karnataka, India *Corresponding author: Aishwarya Hiremath, Department of Pharmaceutics, Rajiv Gandhi University of Health Sciences, Karnataka, India, Tel: 9964097666; E-mail: [email protected] Received: 11-December-2023, Manuscript no: DPC-23-122513, Editor assigned: 14-December-2023, Pre QC No: DPC-23-122513 (PQ), Reviewed: 29-December-2023, QC No: DPC-23-122513, Revised: 01-February-2024, Manuscript No: DPC-23-122513 (R), Published: 11February-2024, DOI: 10.4172/0975-413X.17.2.638-642 ABSTRACT Objective: The objective of this study was to mask the bitterness of lornoxicam by inclusion complex method using β cyclodextrin (β CD), to prepare lornoxicam effervescent tablets with antacids by wet granulation method using citric acid, tartaric acid with sodium bicarbonate as effervescent mixture, which is useful to neutralize the acid that may be occurred due to the co-administration of lornoxicam and to compare the in vitro drug release and Acid Neutralizing Capacity (ANC) of tablets of optimized batch with marketed products. Methods: Authentication of lornoxicam was done by FTIR and DSC analysis. The spectral interference of the excipients at analytical wavelength of lornoxicam was studied using UV method. Prepared tablets of lornoxicam then subjected to evaluation of post compression parameters such as thickness and diameter, wetting time, weight variation, hardness, friability, disintegration, dissolution and Acid Neutralizing Capacity (ANC). Drug release profile and ANC of the tablets of optimized batch F-9 were compared with that of the marketed products, further studied for their reproducibility and stability. Results: FTIR and DSC analysis revealed that the received drug was pure lornoxicam. The excipients were showing no absorbance at analytical wavelength of lornoxicam (289.20 nm). The tablets of all the batches were pass the post compression parameters. The tablets of optimized batch F-9 were able to produce release of 100% drug within 5 min with 12.65 ± 0.160 mEq of ANC. The tablets were found to be reproducible and stable after stability studies. Conclusion: Effervescent tablets of lornoxicam with antacids can be efficiently and successfully formulated by wet granulation method with addition of superdisintegrant. The prepared tablets of lornoxicam with sodium saccharin can be chewed and alternatively used as fast dissolving tablets, as it undergoes disintegration within 40 seconds and increases patient compliance, in addition they were able to produce faster dissolution and better ANC than that of the marketed products. Keywords: Effervescent tablets; Lornoxicam; Inclusion complex; Superdisintegrant; Effervescent mixture; Crosspovidone; Fast dissolving tablets INTRODUCTION The per oral dosage forms (tablet and capsule) have vast range of acceptance of 50-60% of total dosage forms because, these can be easily administered, manufactured, pact in nature and can be given in exact dose. Per oral dosage forms suffering from decelerated absorption and thus slow onset of action, this can be avoided by administrating the drug in liquid form but, several APIs have restricted level of stability in liquid form. Hence, effervescent tablets can be considered as a substituent dosage form. In modern years Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) have acquired great attention in the treatment of inflammation and to supress the pain resulting from wound and infection. The important reason behind such an attention is that NSAIDs are does not produce narcotic effects like narcotic analgesics because of that, these are also called as non-narcotic analgesics. The common NSAIDs available in the market are salicylates, ibuprofen, naproxen, diclofenac, meloxicam, lornoxicam, etc. The NSAIDs mainly causes Gastrointestinal Tract (GIT) toxicity. If NSAIDs are used for longer duration, in the treatment of chronic disease like arthritis will definitely causes the acidity followed by ulcers and porosity. Around the world, on a daily basis, more than 35 million people consume these drugs. Amongst them 30% of users may develop sufficient degree of GI toxicity. It has also been assumed that one third of the cost of treating arthritis patients relates to treatment of the side effects of NSAIDs. Conservative calculation estimated that, nearly 1, 07, 000 patients are hospitalised annually for NSAID related GI complexities like ulcers and porosity. Five to 15 percent of patients, who are taking NSAIDs for the treatment of rheumatoid arthritis, can be expected to discontinue the therapy within a six-month period of treatment, because Aishwarya Hiremath, et al. Der Pharma Chemica, 2025, 17(2): 638-642 469 of occurrence of new gastric and duodenal ulcers. To treat such conditions physicians will prescribe an antacid tablet along with the NSAIDs like lornoxicam. To avoid intake of two tablets, it was thought to combine both NSAID and antacid, to formulate an effervescent tablet which contains both the actives. This study deals with formulation of a combined antacid and analgesic antacid effervescent tablet, this is useful to neutralise the acid that could be released due to co-administration of a lornoxicam. Lornoxicam is used as a model analgesic drug, the mixture of aluminium hydroxide and magnesium hydroxide is used as the model antacid, tartaric acid and citric acid in combination with sodium bicarbonate is being used as the effervescent mixture in 2:1:3.4 ratios to get good effervescence. This preparation can also be dispensed in the form of granules in unit sachets. Lornoxicam is a new NSAID derived from oxicams, belongs to the Class II drug in BCS classification. Lornoxicam is an anti-inflammatory and analgesic drug acts by inhibiting the prostaglandin and thromboxane synthesis through the inhibition of both COX-1 and COX-2 which are responsible for the inflammation and elevated body temperature (Figure 1) [1]. Figure 1: Chemical Structure of Lornoxicam. Lornoxicam is extremely bitter in taste. Therefore, to provide this drug in a more convenient and patient compliant form, an effort was made in this study, to mask the bitter taste of lornoxicam and establish it in the form of effervescent tablet, it can even be chewed, in case of the inability to obtain the water. The lornoxicam inclusion complxes were prepared to mask the bitter taste of the drug, by adopting Lor: beta cyclodextrin (βCD) in 1:2 molar ratio using Polytron High Speed Mixer, Kinematic–Japan (Figure 2). The effervescent tablet to be added to water just before administration and the drug dispersion or solution is to be drunk immediately. In presence of water, an interaction between tartar acid and citric acid will occur with alkali metal carbonates or bicarbonates which internally liberate CO2 in water so that the tablet quickly breaks off [2]. Figure 2: Phase changes of effervescent tablets in water. Antacids are widely used to relieve mild and frequent symptoms associated with acidrelated disease. They act by neutralizing gastric acid and thus increasing gastric pH. The magnesium containing antacids may cause dose-related osmotic diarrhoea. But combining it with aluminium salts which can cause constipation when used alone can offset this side effect. The aluminium and magnesium hydroxide were both used with a substantial dosage 250 mg each in the proposed study, in conjunction, because the elevation of intragastric pH is dose-dependent and usually requires a substantial dose of antacids to raise the intragastric pH above 4 or 5. MATERIALS AND METHODS Materials Lornoxicam pure drug was received from Zydus Research Centre, Ahmedabad. Aluminium hydroxide, magnesium hydroxide, citric acid, tartaric acid, crospovidone, sodium hydroxide, and all of the other reagents and chemicals used were of pharmaceutical grade [3]. Method Authentication of lornoxicam Melting point: The melting point of lornoxicam (API, purified drug) was determined using a programmed melting point apparatus (DBK instruments, Mumbai), and the melting temperature of the drug was measured. FTIR: FTIR studies were conducted using 8300 Spectrophotometer (Shimadzu, Kyoto, Japan) with potassium bromide pellet method. The source provided a continuous spectrum of radiation ranging between 4000 to 400 cm-1. Differential scanning calorimetry: Lornoxicam was subjected differential scanning calorimetry analysis using DSC-60 (Shimadzu, Kyoto, Japan) calorimeter. The melting point of lornoxicam was recorded from the obtained DSC of lornoxicam and compared with the literature value. Analytical method In the range between 5 and 30 µg/ml, a series of lornoxicam solutions were prepared, where the drug obeys beer’s lamberts law. 10 µg/ml solution was scanned in UV visible spectrophotometer in the wavelength range of 200-400 nm using phosphate buffer solution, pH 7.4 as blank, to get absorption maxima of lornoxicam [4]. Spectral interference with analytical wavelength of lornoxicam Aishwarya Hiremath, et al. Der Pharma Chemica, 2025, 17(2): 638-642 470 Since excipients were used along with the lornoxicam in the tablets, it was necessary to identify the interference of excipients with the analytical wavelength, 289.20 nm. The solutions of lornoxicam, antacids and other excipients were prepared at highest concentrations used in formulations. Spectral interference was studied by scanning the solutions in the UV region of 200 to 400 nm. Formulation development Preparation of lornoxicam - cyclodextrin inclusion complexes Lornoxicam drug is highly bitter in taste, hence to mask the bitter taste of the drug inclusion complexes were prepared. The complexes were prepared taking lornoxicam and β-cyclodextrin in 1:2 molar ratio. Based on the saturation solubility study, 80%v/v ethanol was selected as the solvent for complexation, which shown highest solubility of lornoxicam. Microwave method: Precisely weighed amounts of lornoxicam (8 mg, molecular weight of 371.82) and β-CD (49 mg, molecular weight of 2269.97) at the molar ratio of 1:2 were taken in ethanol 80% (v/v) at 60 °C. After that the solution was kept in microwave at 60°C for 90 seconds. The solvent was evaporated under oven and the collected residue was pulverized and sized through sieve no. 60. Co-evaporation method: Precisely weighed amounts of lornoxicam and β-CD at the molar ratio of 1:2 were taken in ethanol 80% (v/v) and stirred by using magnetic stirrer at 60°C. The resultant solution was dried in an oven, pulverized and sized. Mixing at high speed (15000 rpm): Precisely weighed amounts of lornoxicam and β-CD at the molar ratio of 1:2 were taken in ethanol 80% (v/v) at 60°C and mixed with a high speed (15000 rpm) by using Polytron, Kinematic mixer for 8 minutes. The solution was dried in an oven at 60°C for 4 hours17 and further 1 hour at 80°C for the complete evaporation of ethanol. Physical mixture: Accurately weighed amounts of lornoxicam at the molar ratio of 1:2 were blended by simple mixing method in a vial for 30 min. This mixture was used further for comparision purpose. Content estimation of lornoxicamin inclusion complexes: Eight mg equivalent weight of complexes and physical mixture were placed in 100 ml phosphate buffer, 7.4 Ph. At 289.20 nm, assayed Spectrophotometrically for drug content [5]. Selection of dose of lornoxicam The drug lornoxicam is available in the market as 4 mg, 8 mg, and 16 mg tablets. Lornoxicam injections are also available in the market. For the purpose of this study, lornoxicama NSAID drug was taken in the concentration of 8 mg. This medium dose was selected to avoid the excess utility of drug with 16 mg dose and also to meet the experimental sensitivity which may not be possible with 4 mg dose. Selection of dose of antacids The antacids available in the market were studied and compositions of widely used antacids are mentioned in the Table 1. It was observed that, the composition of antacids is not same. They used different antacids to get Acid Neutralizing Capacity (ANC) of 12.4 to 17.4 mEq. In the proposed formulation, antacid was planned to add with lornoxicam (NSAID). Hence it was aimed to get minimum ANC of 12.4 mEq [6]. Table 1: Data of compositions of marketed antacid tablets. Name of antacid Name of the company Ingredients (mg) Al(OH)3 Mg(OH)2 Mg CO3 Mg. Trisilicate Mg. Al. Silicate NaHCO3 Digene Abbott 300 25 - - 50 - Entasid Cadila 250 250 - - 250 - Gelusil MPS Pfizer 250 250 - - 50 - Almacarb GSK 325 - 50 - - - Embesil Nicholas 380 185 - - - - Gaviscon GSK 100 - - 25 - 170 Practol Zydus 500 - - - - - PFT Reckitt Piramal Ltd. 400 400 - - - - Reflux Forte Dr. Reddy’s 300 150 - - - - Sebella Wyeth 426 - - - - - Wet granulation method The wet granulation technique is used for the manufacturing of tablets by using polyvinyl alcohol as binding agent, the tablets so prepared were very hard and did not undergo disintegration in the limits stated by IP in spite of effervescent agents present in the tablets. Binder was changed to polyvinyl pyrolidone but the tablets posed the same problem. Finally the idea of using absolute alcohol as a binder was implemented just to increase the density of the tablet blend. The tablets passed for the disintegration test. Lornoxicam complex, aluminium hydroxide gel, citric acid, magnesium hydroxide, tartaric acid, crosspovidone, sodium bicarbonate, sodium saccharin, and microcrystalline cellulose were passed through sieve #60. Required amount of all the above ingredients were weighed accurately and mixed in a polybag by geometric addition method for 20 minutes, manually and added peppermint flavour. Absolute alcohol is used to granulate the powder mix. The dough mass sifted through sieve (8 #), the granules dried using conventional hot air oven at 60°C. The sieves of size #20/#40 were used to sift the dried grnules, lubricated with talc (2%w/w). The compaction of powder mixture was done on 10 stations rotary compression machine (Rimek, Nanikadi) using 12.5 mm hexagonal shaped punch. Design of formulations: Development of the formulation in the proposed study was mainly based on the different concentrations of effervescent mixture followed by randomly selected method of decreasing the concentration the effervescent mixture with same concentration Aishwarya Hiremath, et al. Der Pharma Chemica, 2025, 17(2): 638-642 471 of antacids and lornoxicam. Talc was utilised as glidant. MCC was utilised as a diluent to get the final weight of the tablet as 850 mg. Other excipients were chosen so as to get tablets with good physical properties. In total, seven different effervescent compositions (F3 to F9) were designed based on the observation made in first two formulations (F1 and F2), as shown in the Table 2. Pre-compression parameters Angle of Repose (θ) The values of angle of repose for tablet mixtures were determined by funnel - method (Reposogram). The exactly weighed tablet blend was made flow freely through the funnel. The funnel was adjusted to a height, so that its tip just touches the peak of the powder cone. The diameter of the cone was determined, and angle of repose is designated by θ and given by equation. θ = tan-1 (h/r) Where, h=the height of the powder cone and r = the radius of the powder cone. Bulk density Tapped Bulk Density (TBD) and Loose Bulk Density (LBD) of the tablet blends were calculated using bulk density apparatus-USP (Electrolab, India). Procedure: Test sample powder having volume in between 40 to 45 ml was taken in a graduated measuring cylinder and initial/basic volume was measured (v1). At the beginning the cylinder was tapped for 500 times. Measured the tapped volume. The tapping was repeated an additional 750. Again the (v2) was measured to the nearest graduated unit. The tapping was repeated until the difference between two volumes was more than 2%. The TBD and LBD were calculated in gm per ml using following formulae; TBD=Weight of the powder/tapped volume of the packing LBD=Weight of the powder/volume of the packing Compressibility Index (Carr’s index) The powder compressibility index was calculated by Carr’s compressibility index. Carr’s index (%) can be calculated by using the following formula: Carr’s index (%)=[(TBD–LBD) x 100]/TBD Hausner’s Ratio The Hausner’s ratio for the powder was calculated by the following equation. Hausner’s ratio=TBD/LBD Table 2: Grading of the powders for their flow properties–Hausner’s ratio. Hausner’s ratio Flow 1.00-1.11 good 1.12-1.18 excellent 1.16-1.25 fair 1.26-1.34 passable 1.35-1.45 poor 1.46-1.59 very poor >1.60 very very poor Post-compression parameters/Evaluation of lornoxicam tablets Appearance The tablets were inspected for the existence of cracks, depressions, pinholes etc., if any and uniformity of the color of the tablet. Dimensions 10 tablets were selected randomly from each batch. Thickness and diameter of the tablets were measured three times using verniercalipers (Mitutuyo, Japan). Weight uniformity test 20 tablets were individually weighed from each batch and the average weight was calculated from total weight of 20 tablets. The individual weights were compared to average weight. The percentage weight difference should be within the permitted limit (± 5.0%) as the tablets weigh 850 mg. Calculated for the percentage deviation using the following formula, Aishwarya Hiremath, et al. Der Pharma Chemica, 2025, 17(2): 638-642 472 Percentage deviation = (Individual weight – Average weight) Average weight ×100 Hardness test Hardness (diametric crushing strength) is a force required to break a tablet across the diameter. The strength of a tablet is determined by its hardness. The tablet should be stable to mechanical stress during handling and transportation. The hardness was determined by using Monsanto Hardness Tester (Sheetal Scientific Industries, Ahmedabad. The average of five determinations was calculated in terms kilograms per centimeter square and reported. Friability test Roche friabilator (Electrolab, Mumbai) was used to measure the friability of the tablets. It is expressed in percents (%). Six tablet were initially weighed (w 1) and transfered into the Friabilator. The rotation was regulated at a speed of 25 rpm. After completion of 100 rotations (4 minutes), tablets from friabilators were taken and the same tablets collectively weighed again (w2). The percent Friability was calculated. Friability = [(w1 – w2)/w1] × 100 Where, w1=weight of the tablets before test and w2 = weight of the tablets after test Content uniformity test Single tablet was powdered and shaken with 100 ml of phosphate buffer solution, pH 7.4 for 60 minutes and filtered. Further, dilutions were made, the absorbance of the resulting solution was measured. The experiment was performed three times and average was calculated. Acid Neutralizing Capacity of Tablet (ANC) Here antacids were used along with a NSAID drug. Amount of hydrochloric acid neutralized by a tablet is called as the acid neutralizing capacity of that tablet and it expressed interms of miliequalant (mEq). This can be determined by a technique called back-titration. The ANC value of a formulation essentially should exceed five mEq per dose (minimal labeled dose) to be considered as an antacid. Procedure: A single tablet was placed in 250ml beaker containing 70 ml water and mixed for 1 min on magnetic stirrer. Pipetted 30 ml of 1 N HCl and added to the test solution, which was prepared as per the above-mentioned procedure and kept with magnetic stirrer. Stirred for 15 min, after the addition of the acid, accurately timed, and titrated within 5 minutes. The extra HCl was titrated against 0.2 N NaOH to achieve a stable pH of 3.5. The ANC was determined. Calculated the amount of acid utilized and presented the results in terms of m Eq. of acid consumed per tablet tested. Disintegration time A single tablet was placed in a 250 ml beaker containing 200 ml of water at 25°C (20-30oC as per IP 2018). Numerous gas bubbles were evolved. Then the evolution of the gas around the tablet or its fragments had ceased. The time noted when the complete tablet gets disintegrated. Test done for 5 more tablets and average was determined. In vitro drug release In vitro release in the environment of gastrointestinal tract was determined for pure lornoxicma drug, lornoxicam complexes and all the developed formulations using the USP – type II, paddle type apparatus (Electrolab, Mumbai). 500 ml of phosphate buffer solution, pH 7.4 was taken as dissolution medium temperature and rpm were maintained at 37 ± 0.5 °C and 50 rpm respectively, 5 ml samples were withdrawn in 5 min interval upto 30 min, the aliquots were analyzed at 289.20 nm on UV spectrophotometer. The % drug release was determined using the standard curve equation and results shown in Figures 9-11. Comparison of dissolution profile of optimized lornoxicam tablet with marketed lornoxicam 8 mg tablets In vitro study of marketed formulation was carried out similar to the procedure given for in vitro drug release of lornoxicam from the developed formulations, in the environment of GI tract. All the conditions were kept maintained as earlier. The collected alequots were analyzed at 289.20 nm using dissolution medium as blank. The cumulative percentage drug release was calculated. Graph of cumulative percentage drug release Vs time (minutes) for all the tablets was plotted and shown in Figure 12. Comparison of ANC of optimized formulation with marketed formulations ANC of marketed formulations (Gelusil MPS and Digene) was carried out similar to the procedure given for ANC of the developed formulations of lornoxicam. This capacity can be determined by a technique called back-titration. Two different brands of antacid marketed products were taken for the study. A single antacid tablet was dissolved in excess of hydrochloric acid and then the excess acid was back titrated with standardized sodium hydroxide solution. ANC was calculated and average result of three trials was taken as ANC of the tablet which are given in Table 9. Reproducibility In order to verify batch to batch uniformity, tablets of the optimized batch F-9 were manufactured for the second time (reproducible batch). All the conditions were kept constant as earlier. The tablets were evaluated for dissolution and ANC as the rest of the parameters were proved to be reproducible and compared with tablets of the earlier batch as given in the Table 10. Aishwarya Hiremath, et al. Der Pharma Chemica, 2025, 17(2): 638-642 473 Stability studies The purpose of stability testing is to prove how the quality of a drug product changes with time under influence of different environmental factors such as temperature and humidity. In the current work stability study was conducted for the tablets optimized formulation F-9 at 40 ± 2°C and 75 ± 5% RH for 6 months. The tablets were checked for post compression tests and compared with tablets which were evaluated immediately after manufacturing. The results were given in Table 12 and Figure 14. RESULTS AND DISCUSSION Authentication of Lornoxicam To check, weather the given drug sample was pure lornoxicam or not, authentication of the sample was done by 3 different tests as followed. Melting Point (MP): lornoxicam exhibited MP of 223.67°C (n=3). This value matches with the literature value. FTIR Study: FTIR studies were conducted on the pure drug lornoxicam using 8300 Spectrophotometer. The source provided a continuous spectrum of radiation ranging between 4000 and 400 cm-1. Intensities of absorption bands were expressed as % transmittance. The sample was prepared using the potassium bromide pellet method. The spectrum was obtained by placing the pellet in the IR chamber and the peak intensities were taken. The peaks found in the spectrum were compared with the data reported in the literature. FT-IR spectrum of pure lornoxicam is shown in the Figure 3 and peaks are listed in Table 3 [7]. Table 3: The peak of functional groups observed in IR spectra of lornoxicam. Functional groups Principal Peaks (cm-1) Standard Peak Region Standard drug N-H bend 1510-1560 (m, s) 1543.05 -C-Hstretch 3010-3100 (m) 3064.89 S=O 1030-1060 1039.63 C=O stretch 1700-1600 (s, broad) 1635.64 C-Clstretch 750-850 (s) 790.81 C=C stretch 1450-1600 (m, s) 1597.06 -C-N 1350-1000 1153.43 Figure 3: FT-IR spectrum of pure lornoxicam. Since different peaks of the API, which are formed due to the presence of different functional groups, were fall within the standard peak region of the respective functional groups. So, the conclusion can be made that, the given API is lornoxicam only. Differential Scanning Calorimetry(DSC) study: DSC analysis of pure drug was performed and the thermogram is shown in the Figure 4. Perusal to the Figure 4, it could be stated that the drug possessed polymorphism. The most stable form of the drug melted at 211.65°C. Later the liquefied drug had undergone polymorphic transition to give less stable or metastable form of lornoxicam. This form again undergone melting at 214.24°C followed by decomposition. These melting points are nearer to the melting point of lornoxicam reported in the literature [8]. Aishwarya Hiremath, et al. Der Pharma Chemica, 2025, 17(2): 638-642 474 Figure 4: DSC of lornoxicam. By looking at the results of these three tests collectively, the conclusion can be made that, the given drug is pure lornoxicam. Analytical Method Lornoxicam in phosphate buffer solution, pH 7.4 showed maximum absorption at 289.20 nm and this wavelength was selected as the analytical wavelength. Beer’s law was obeyed in the range between 5 to 30 µg/ml. Regression equation for standard curve was y = 0.0329x + 0.0015. Correlation coefficient was found to be 0.9999 signifying that the linear relationship between concentration of the drug and absorbance. Spectral interference with analytical wavelength of lornoxicam Excipients, if not all, used were organic substances and were suspected to absorb UV radiation interfering lornoxicam estimation. Therefore, interference of excipients with the estimation of lornoxicam was studied. The spectra for pure lornoxicam shown in Figure 5. The spectra for lornoxicam and excipients are shown in Figures 7 to 9. Perusal to the Figures 6 to 8 indicated that excipients did not interfere with the estimation of lornoxicam. Thus, the selected λmax 289.20 nm was suitable as an analytical wavelength [9]. Figure 5: UV-spectrum of lornoxicam in phosphate buffer solution, pH 7.4. Spectral Interference with Analytical Wavelength of Lornoxicam. Figure 6: UV absorption spectra of lornoxicam (8 mg/ml), Aluminum hydroxide solution (250 µg/ml), Magnesium hydroxide solution (250µg/ml), β cyclodextrin in phosphate buffer solution (pH 7.4). Aishwarya Hiremath, et al. Der Pharma Chemica, 2025, 17(2): 638-642 475 Figure 7: UV absorption spectra of lornoxicam (8 mg/ml), Citric acid solution (35 µg/ml), Tartaric acid solition (70 µg/ml), Sodium bicarbonate (51µg/ml), in phosphate buffer solution (pH 7.4). Figure 8: UV absorption spectra of lornoxicam (8 mg/ml), sodium saccharin solution (5 µg/ml), microcrystalline cellulose (133 µg/ml), crospovidone solution (43 µg/ml) in phosphate buffer solution (pH 7.4). Content estimation of lornoxicam in inclusion complexes Lornoxicam content was determined in all the complexes prepared by different methods. The results are given in the Table 4 [10]. Table 4: Data for content estimation of lornoxicam in inclusion complexes. Method Absorbance* Mean ± SD Microwave method 0.376 ± 0.03 Co-evaporation method 0.346 ± 0.027 Mixing at high speed (15000 rpm) 0.763 ± 0.007 Physicalmixing method 0.304 ± 0.017 *Each value is an average of six determinations The results revealed that, the complexes developed using the method ‘mixing at high speed (15000 rpm) have shown maximum lornoxicam content. Therefore, these complexes were used further to develop the formulation. Design of formulations: Masking the bitter taste of the lornoxicam drug and formulating it with the antacids was the heart of the experiment and was very important to formulate the effervescent tablets which are able to produce in vitro disintegration within 5 minutes as per IP standards (Tables 5 and 6) [11]. Table 5: Formulations of lornoxicam effervescent tablets. Ingredients (mg) F1 F2 F3 F4 F5 F6 F7 F8 F9 Lornoxicam complex (equivalent to 8 mg drug) 57 57 57 57 57 57 57 57 57 Aluminium hydroxide gel 25 0 250 250 250 250 250 250 250 250 Magnesium hydroxide 25 0 250 250 250 250 250 250 250 250 Citric acid 35 - 35 30 25 20 15 10 5 Tartaric acid 70 - 70 60 50 40 30 20 10 Aishwarya Hiremath, et al. Der Pharma Chemica, 2025, 17(2): 638-642 476 Sodium bicarbonate 11 9 - 119 102 85 68 51 34 17 Crosspovidone (5%) - 42.5 42. 5 42. 5 42. 5 42.5 42.5 42.5 42.5 Sodium saccharin 5 5 5 5 5 5 5 5 5 Talc (2%) 17 17 17 17 17 17 17 17 17 MCC 47 228. 5 4.5 36. 5 68. 5 100. 5 132. 5 164. 5 196. 5 Total weight of tablet 85 0 850 850 850 850 850 850 850 850 Table 6: Physical properties of the powder-blends for the batches F-1 to F-9. Parameter F-1 F-2 F-3 F-4 F-5 F-6 F-7 F-8 F-9 Loose bulk density (gm/cc) 0.378 0.378 0.366 0.356 0.38 0.39 0.367 0.384 0.396 Tapped bulk density (gm/cc) 0.491 0.504 0.485 0.475 0.5 0.52 0.488 0.51 0.52 Angle of repose (°) 39.7 37.35 39 38.89 39.2 41.01 39 38.8 39.5 Compressibility index (%) 23 25 24.5 24.2 24 25 24.7 24.7 23.84 Hausner ratio 1.298 1.33 1.325 1.342 1.32 1.33 1.329 1.328 1.313 The tablets were prepared, after getting all physical properties of the powder-blend satisfactory. The tablets were subjected to evaluation for the post compression parameters. The results are given in the Tables 7 [12]. Table 7: Properties of lornoxicam effervescent tablets for the batch F-1 to F-9. Parameters F-1 F-2 F-3 F-4 F-5 F-6 F-7 F-8 F-9 Hardness (kg/cm2)* 1.86 2.36 2.16 3.4 2.5 2.166 5.33 5.53 3.966 ± 0.32 ± 0.23 ± 0.28 ± 0.5 ± 0.5 ± 0.28 ± 0.57 ± 0.5 ± 0.5 Friability (%)# 1.4 0.8 1.11 1.1 1.12 1.01 0.87 0.58 0.21 Uniformity of weight (mg)# 848.9 850.8 848.5 849.3 849.4 848.7 850.6 849.5 849.2 ± 0.89 ± 0.2 ± 0.4 ± 0.7 ± 0.4 ± 0.9 ± 0.1 ± 0.4 ± 0.7 Drug content (%)** 98.62 99.98 ± 0.57 101.1 99.8 98.3 98.73 99.9 100.1 99.9 ± 1.2 ± 1.4 ± 1.65 ± 1.9 ± 1.8 ±1.67 ±1.4 ± 1.67 Thickness (mm)* 8.7 8.1 8.11 8.13 8.85 8.86 8.11 8.18 8.12 ±0.01 ±0.05 ±0.13 ±0.05 ±0.0 1 ±0.03 ±0.04 ±0.1 1 ±0.04 Diameter (mm)* 12.08 12.01 12.1 12.1 12.09 12.1 12.09 12.09 12.1 ±0.03 ±0.04 ±0.04 ±0.08 ±0.0 1 ±0.02 ±0.01 ±0.0 3 ±0.00 8 Wetting time (seconds)** 133 50.8 274 200 125 121 43.3 50 35 ±0.04 ±0.02 ±0.07 ±0.01 ±0.2 ±0.3 ±0.13 ±0.2 ±0.01 disintegraion time (seconds)* 59.3 150 300 240 140 130 50 60 40 ±0.01 ±0.13 .±0.2 ±0.01 ±0.1 2 ±0.07 ±0.2 ±0.1 ±0.1 pH 8 8.24 8.06 8.16 8.17 8.18 8.16 8.17 8.1 *Each value was an average of six determinations **Each value was an average of three determinations #Results of one batch Dissolution Profiles