Uncoated Tablets Research Articles

Esophageal transit of solid oral dosage forms – impact of different surface materials characterized in vitro and in vivo by MRI in healthy volunteers

Acceptable swallowability and complete esophageal transit are decisive for the safe and effective administration of solid oral dosage forms. This applies in particular to the main user group of medicines, older adults, who often suffer from swallowing difficulties. It is well known that surface properties play an important role in this respect. In the past, this has led to the development of numerous coating formulations for tablets with improved swallowability. However, in vitro and especially in vivo data investigating a positive effect of different coating materials is limited. Therefore, we investigated coating materials being based on polyvinyl alcohol, hydroxypropyl methylcellulose, and a copolymer of methacrylate in respect to their influence on swallowability and esophageal transit of a tablet formulation. They were compared to uncoated tablets as well as to hard gelatin capsules. Three in vitro assays suitable for routine use in pharmaceutical development were performed: i.) Wettability test in artificial saliva; ii.) Swelling measurement in artificial saliva; iii.) Measurement of the adhesion between surface materials and a simulated mucosa surface. All three assays resulted in a differentiation of the surface materials. The coated tablets showed favorable behavior compared to uncoated tablets and hard gelatin capsules. To test the effect of the different materials in vivo, an intervention study was conducted. 36 adults were included and the likeliness of prolonged esophageal transit of (un-)coated tablets as well as a hard gelatin capsule of the same weight was objectively evaluated by means of magnetic resonance imaging. While hard gelatin capsules showed highest rates for prolonged esophageal transit, the tendency for adhesion was reduced for uncoated tablets, and least for coated tablets, i.e., prolonged esophageal transit in 22.2 %, 11.1 %, and ≤5.6 % of the cases, respectively. Further differentiation of the coating materials was not possible. Subjective evaluations of each participant with respect to subjective swallowability and esophageal transit did not correlate well with the objective measurements by means of magnetic resonance imaging. The use of coatings in general has a positive influence on esophageal transit. However, the selection of coating type seems to be of greater importance in respect to patients' oral perception of the dosage forms compared to their influence on the probability for prolonged esophageal transit.

Development of Solventless Pharmaceutical Technique for Manufacture of Pharmaceuticals

The aim of our study was to develop a solventless drug pelletization and polymer coating technique for pharmaceutical manufacturing. This review describes a dry coating technique using a mechanical powder processor and a V-shaped blender to produce coated pellets or tablets by mechanically mixing polymer particles and core materials (such as drug pellets and uncoated tablets) without the need for a solvent. First, aqueous latexes comprising colloidal polymethacrylates and ethylcellulose were solidified by freeze drying to produce polymer particles for the dry coating process. These particles and the cores were then subjected to mechanical powder processing or V-shaped blending to provide coated formulations with controlled-release characteristics. Polymer coating was achieved by using agglomerates comprising assembled colloidal polymer. The agglomerated polymer was easily pulverized during the mixing treatments due to its loose structure (the lack of close contacts between the colloidal particles), and the resulting fine polymer with high adhesiveness was deposited on the cores. Colloidal polymer dispersed in aqueous latex tends to coagulate in the freeze-drying process due to condensation of the dispersion, yielding dense agglomerates with poor coating characteristics. The presence of surfactants (such as sodium lauryl sulfate) in the latex can prevent adhesion between colloidal particles in the freeze-drying process, providing loosely structured agglomerates suitable for dry coating. Dry coating with a V-shaped blender could thus be achieved with these polymer particles instead of having to use a mechanical powder processor.

Effect of kyron T-134 and crospovidone as a fast disintegrating agent on formulation properties of fast dissolving tablet containing ketorolac and rizatriptan using direct compression method

Background and objective: Fast dissolving tablets (FDTs) are "they are uncoated tablets that are supposed to be placed in the mouth and dispersed quickly before being swallowed" within minutes. This study aimed to formulate and evaluate a combination of ketorolac and rizatriptan as orally fast-dissolving tablets using the most common and easiest method to treat migraine attacks with or without aura. To investigate the effects of various types of diluents and super disintegrants on wetting time, water absorption ratio, disintegration, and dissolution time of combined drugs (ketorolac and rizatriptan) as oral dissolving tablets prepared by direct compression technique. Methods: Pre-formulation experiments were carried out in order to rule out any physicochemical interactions between the two medications (ketorolac and rizatriptan) as well as between each drug and its excipients. Four different formulations of fast-dissolving tablets with different types and ratios of diluents and super disintegrants were created using the direct compression technique in order to improve the formulation. Organoleptic characteristics, weight variation, thickness, friability, hardness, disintegration duration, wetting duration, water absorption ratio, drug content, in-vitro dissolution, stability, and comparison tests have all been characterized. Results: According to FT-IR, the two drugs and excipients exhibit no physicochemical interactions. The ideal formula F4 contains crospovidone and Kyron T-134 at optimal concentrations of 2.5% and 2.5%, respectively, and provides the majority of pharmaceutical drugs to be released within the first five minutes, a strong stability profile, the shortest wetting time with the fastest disintegration time (10 sec), and a pleasant flavor (strawberry flavoring agent). Conclusion: Kyron T-134 with Crospovidone in a (1:1) ratio provided rapid disintegration. Ketorolac tromethamine and rizatriptan benzoate may be made into fast-dissolving oral tablets using Kyron T-134 and Crospovidone. Improving migraine compliance is a reasonable goal.

In vivo assessment, formulation, characterization and enhancing pharmacotherapy of encapsulated mini tablets for immediate release Sildenafil citrate and sustained release Bosentan

The purpose of this study was to prepare and evaluate multiple unit mini tablets (MTs) of prolonged released (PR) bosentan (BSN) and fast release (FR) sildenafil citrate (SDC) on the basis of encapsulation method for the effective management of pulmonary artery hypertension. The system consists of MTs are in the form of uncoated tablets containing the superdisintegrating agents where as the PRMTs contains the polymer with film coating. All the units are prepared by direct compression method and encapsulated using size 1 hard gelatin capsule shells. The formulations were evaluated for differential scanning calorimetry, dissolution test and post compression studies for their quality attributes and it was found that all the parameters were in the acceptable limits. The optimized formulation for BSN PRMTs i.e BS3 which contains 5 % HPMC K15M shows a promising sustained release profile of 82.31 % in 24 h similarly FRMTs of SDC of formulation SD6 that having 3 % of magnesium aluminium silicate shows about 90 % of drug release within 15 min. The in-vivo pharmacokinetic characterization of the system was carried out using wister rats where the AUC value for SDC FRMTs and BSN PRMTs was found to be 94256.88625 ± 123.65 ng h/mL and 142438.084 ± 324.11 ng h/mL respectively. The other pharmacokinetics are also determined and found to be satisfactory. The six months stability samples showed no significant change in the drug content, hardness and uniformity of the content of the optimized formulations.

Quality Assurance and In-vitro Bioequivalence Analysis of Amlodipine Besylate Tablets

The proliferation of generic brands in the local pharmaceutical market makes it increasingly difficult for health professionals and patients to choose the optimal drug. The study aimed to assess the physicochemical parameters of generic amlodipine besylate tablets utilizing in-vitro testing to eliminate health hazards and maximize safety. Five brands (A, B, C, D, and E) of amlodipine besylate tablets (5 mg) were examined for six in-vitro tests; thickness, hardness, friability, uniformity of weight, disintegration, dissolution, and thin layer chromatography (TLC). The dissolution test revealed that Brand D had the highest percentage of drug release at 5 minutes (106.2%), followed by Brand E (103.2%), A (70.7%), B (64.4%), and C (61.0%), respectively. The spectrophotometric measurement was carried out at 240 nm. All five brands satisfied the British Pharmacopeia standard for uncoated tablet weight homogeneity (less than 5% variance) and disintegration within 15 minutes. Brand A has the longest disintegration time (4.37 minutes), whereas Brand B has the shortest (3.05). Brand E had the maximum hardness of 8.7 kg/cm², and Brand B had the lowest hardness of 3 kg/cm². All five brands had a friability percentage of less than 1%, with bread B having the highest (0.91%) and brand E, lowest (0.10%), all tablets crumbled after 15 minutes. All brands passed the quality assessment test. Conclusion: The Quality Assurance and in-vitro bioequivalence assay methods used in this study are dependable, simple, and inexpensive, and they can be used consistently to evaluate amlodipine tablets and other solid-dosage pharmaceutical products.

Investigation of long-term stability of a transmission Raman calibration model using orthogonal projection methods

Transmission Raman Spectroscopy (TRS) was implemented as an ‘Extended’ Content Uniformity (ECU) method for un-coated tablets for a commercial pharmaceutical product. By sampling un-coated tablets throughout the duration of the tablet compression stage, it can be demonstrated that the material from the preceding blend step was of uniform composition, and therefore the blend and compression unit-operations were in a state of control. TRS was selected as a rapid, non-destructive measurement that can be automated through the use of a sample tray that can hold many tablets. In this work, the performance of a multivariate calibration model (PLS) deployed to two Transmission Raman Spectrometers co-located within the same QC laboratory was studied using data obtained over a 3-year period. The aim of the investigation was to assess the impact of various annual instrument maintenance events, and to evaluate several chemometric methods for reducing or eliminating the spectral effects that led to deterioration of a models performance. Linear orthogonal projection approaches such as Transfer by Orthogonal Projection (TOP), Dynamic Orthogonal Projection (DOP) and Unsupervised Dynamic Orthogonal Projection (uDOP) were applied, along with a more recent, non-linear method called Transfer Component Analysis-Orthogonal Projection (TCA-OP). This works shows that each method has merits, depending on the nature of the spectral/model correction required. In most cases, the model performance could be fully restored, or significantly improved. This work also highlights how these various methods can be useful tools to better understand the root-cause for a deterioration in model performance.

Feasibility study of the use of a homemade direct powder extrusion printer to manufacture printed tablets with an immediate release of a BCS II molecule

Among the various 3D printing techniques, FDM is the most studied in pharmaceutical research. However, it requires the fabrication of filaments with suitable mechanical properties using HME, which can be laborious and time-consuming. DPE has emerged as a single-step printing technique that can overcome FDM limits as it enables the direct printing of powder blends without the need of filaments. This study demonstrated the manufacturing of cylindrical-shaped printed tablets containing CBD, a BCS II molecule, with an immediate release. Different blends of PEO/E100 and PEO/SOL, each with 10 % of CBD, were printed and tested according to the Eur. Ph. for uncoated tablets. Each printed cylinder met the Eur. Ph. specifications for friability, mass variation and mass uniformity. However, only the E100-based formulations enabled a CBD immediate release, as formulations containing SOL formed a gel once in contact with the dissolution medium, reducing the drug dissolution rate.

Comparative Evaluation of Sweet Potato and Peas Starches as Disintegrants in the Foundation of Paracetamol Tablets

Starch is used as an excipient in pharmaceutical dosage forms such as binder, diluent, disintegrant, absorbent, glidant and sweetener. Starch also has industrial applications as a viscosifier, defoaming and emulsifying agent. However, most of the starch used for these purposes is corn starch and is obtained by importation into Uganda from other countries, which results in a lot of money being utilized in importation of the corn starch which affects the cost of the final products formulated from this starch. The purpose of this research was to determine the disintegrant properties of sweet potato and pea starches in paracetamol tablets. Sweet potatoes and peas are grown locally, hence can be used as alternative sources of starch to corn starch so that the costs of production for pharmaceutical products that require starch can be reduced. In this study, I extracted starch from peas and sweet potatoes in the laboratory and then used it as a disintegrant to formulate paracetamol tablets using the wet granulation method. From the results obtained, starch powders extracted from both peas and sweet potatoes passed the tests that make them suitable for use for pharmaceutical purposes, and the paracetamol tablets formulated using the two starches as disintegrants had the desired disintegration time. However, the results indicated that peas starch had better disintegrant properties than sweet potato starch when used as disintegrants in the formulation of paracetamol tablets. All the paracetamol tablets disintegrated before 15 minutes as recommended by the Bp specification of disintegration time of less or equal to 15 minutes for uncoated tablets. The paracetamol tablets formulated using starch from peas and sweet potatoes disintegrated within 9 minutes and 10 minutes respectively. Keywords: Disintegrant properties, Sweet potato and pea starches, Pharmaceutical products, Paracetamol tablets, Corn starch.

The effect of particle size on the sublimation behavior of butylhydroxytoluene as antioxidant in tablets during storage and coating

The effect of particle size on the sublimation behavior of butylhydroxytoluene (BHT) was investigated when BHT was included as antioxidant in tablets. Sublimation of pure BHT was found to be independent of its particle size, with pore formation on the surface of all tablets after storage at room temperature and above. Moreover, a higher residual BHT content after storage was detected in tablets containing a larger size fraction. X-ray µCT scans revealed the formation of peripherally larger pores at higher BHT particle sizes, implying a slower sublimation rate in the tablet core. A stability study indicated an increase in the extent of BHT sublimation at higher temperature and longer exposure time for all size fractions. The influence of BHT particle size was more pronounced when the tablets were stored at higher temperature, but the effect receded with longer exposure time. Similar trends were seen in film-coated tablets. Due to the short exposure time to elevated temperatures, a gradient in pore size was also observed at smaller particle sizes, with peripheral pores being larger in uncoated tablets. Superficial pores disappeared when a film coating was deposited onto the tablets. After storage of the film-coated tablets, less BHT had sublimated compared to the uncoated tablet. The coating layer did not prevent sublimation, but the process was slowed down.

EVALUATION OF METRONIDAZOLE TABLETS FORMULATED WITH DIFFERENT DISINTEGRANTS USING MOISTURE ACTIVATED DRY GRANULATION

Introduction: Metronidazole is a synthetic oral nitroimidazole antibiotic used in the treatment of infections caused by anaerobic bacteria and protozoa. It also has amebicidal and antiprotozoal properties. Aim: The purpose of the study was to formulate and evaluate metronidazole tablets formulated with polymers (PVP and PEG) and maize starch as disintegrant using moisture activated dry granulation (MADG). Method: Twenty-four (24) batches of metronidazole granules and tablets were prepared by moisture activated dry granulation. Metronidazole (200 mg), lactose and gelatin (1, 2, 4, and 8 %) were mixed, followed by continuous mixing. Prior to compression, micro-crystalline cellulose, disintegrants and magnesium stearate were added. The dried granules were passed via 1.0 mm sieve after which they were labelled and stored in an air tight container. All other batches were also similarly prepared. Result: The result showed that the mean weight of the tablets ranged from 0.33±0.01 to 0.35±0.04 g. Tablet hardness ranged from 5.00±0.85 to 6.36±1.43. The results showed that batch 11 tablets had higher crushing strength than batch 24 with a significant difference. Table 2 shows the hardness test results and clearly indicates that the results of all the samples significantly differ from each other (p<0.05). The tablet friability test ranged from 0.21±0.17 for batch 24 and 0.60±0.16 for batch 11. The formulated tablets showed average disintegration time ranges from 0.52±0.01 to 14.03±0.03. According to USP, the disintegration time must be in the range of 15 min for uncoated tablets, and 30 mins for film coated tablets. Conclusion: The study established that polyethylene glycol and polyvinyl pyrrolidone polymers had better dissolution profile than maize starch which has the best disintegration properties. Peer Review History: Received: 4 March 2023; Revised: 26 April; Accepted: 20 June 2023, Available online: 15 July 2023 Academic Editor: Dr. Jennifer Audu-Peter, University of Jos, Nigeria, drambia44@gmail.com Received file: Reviewer's Comments: Average Peer review marks at initial stage: 5.0/10 Average Peer review marks at publication stage: 7.0/10 Reviewers: Dr. Julie Ann S. Ng, Blk 18 Lot 6 Grandville 3 Subdivision Mansilingan, Bacolod City, Philippines. julieann_ng@yahoo.com Dr. Essam Mohamed Eissa, Beni-Suef – 32 Tahrir St, Egypt, dressamceutics@yahoo.com

Physicochemical and In-Vitro Bioequivalence Analysis of Some Oral Solid-Dosage Metronidazole Formulations

Background: Metronidazole is a 5-nitroimidazole antimicrobial agent, widely used in the treatment of infections caused by Trichomonas vaginalis, such as trichomoniasis, pseudomembranous colitis, and symptomatic amoebiasis resulting from anaerobic bacteria. Aim: The study aimed to qualitatively determine the quality and in-vitrobioequivalence of selected brands of metronidazole tablet dosage forms used in the management of infectious diseases. Method: The British Pharmacopeia (BP) Standard methods were followed to conduct weight uniformity, disintegration time, hardness, and friability tests. For the Thin Layer Chromatographic (TLC) Fingerprinting, 0.1g of the brands were weighed and dissolved ins 50 ml methanol (50%). The stock solution was prepared using 50% methanol and 50% dichloromethane and was transferred into the Chamber and allowed to stand for about 45 minutes; the plates were viewed under UV-VIS Spectrophotometer at 365 nm. Result: All the brands complied with the acceptable friability limit, and disintegrated within the appropriate time of not more than 15 minutes as specified in BP, for uncoated tablets. The tablets were found to have a dissolution profile of at least 70% of the active ingredient taken at 45 minutes from the dissolution medium as stated in BP. The analysis showed the consistency of concentration of the selected tablet brands with the label claims. Conclusion: The TLC procedure used in the analysis was accurate and precise, no interference was observed from the excipients. Thus, this method can be used in the routine quality control of metronidazole solid dosage form.

Solventless Drug Pelletization and Polymer Coating Techniques for Pharmaceutical Manufacturing

This paper described a review of solventless drug pelletization and polymer coating techniques using a mechanical powder processor as well as conventional processors including a high shear granulator and a V-shaped blender. Mechanical powder processing of drug crystals provided pellets comprising drug alone and the pelletization was due to inherent adhesiveness of drug powder as well as mechanically-induced dehydration or amorphization of drug crystals. Mechanical powder coating of polymethacrylates and ethylcellulose was achieved using freeze dried powder comprising colloidal polymer particles. High shear mixing of drug crystals and cellulose spheres provided drug-layered pellets by ball-milling actions of the spheres in the granulator. V-shaped blending of uncoated tablets and colloidal polymer powder resulted in the coating of the tablets with broken polymer particles. These techniques include only simple mixing processes and need no solvents, thereby contributing to the reduction of the environment impacts and costs in pharmaceutical manufacturing.

Discriminative Disintegration Techniques For Various Brands of NimesulideTablets Available in the Market

Background Nimesulide is a non-steroidal anti-inflammatory selective inhibitor of the enzyme cyclooxygenase with analgesic and antipyretic properties. It is approved to treat acute pain symptomatic treatment of osteoarthritis and primary dysmenorrhoea in adolescents and adults above 12 years age.Objective This article describes the recent research on the bioequivalence of six brands of Nimesulide tablets. Due to the large variety of Nimesulide tablet brands accessible in the Indian market medical practitioners face a tough challenge of selecting the best brand or using alternative treatments. The study presented assessed all six tablet brands in accordance with Indian Pharmacopoeia IP guidelines and the appropriate methods were provided for choosing the best options.Methodology All six tablet brands were evaluated utilizing in vitro tests using various evaluation techniques. Six different brands of tablets were used in the in vitro dissolving experiment and all of the tablets cleared the standards for general quality evaluation tests such as hardness friability disintegration time and dissolve time. All of the tested brands met the requirements for the disintegration time. With the exception of brand names Nimek and Bigesic every brand released more than 45 of the Nimesulide after 30 min. Auronim Novogesic Zega and Nise have a very sluggish rate of dissolution which indicates that their bioavailability is most likely to be low. The variations in the reported dissolving profiles could be due to differences between the manufacturers in terms of formulation ingredients the physical form of medicine used in the tablet and the manufacturing method.Results The result emphasizes the importance of continuous monitoring of new Nimesulide brands introduced to the drug market to ensure bioequivalence and compliance with pharmacopoeia standards.Conclusion The results conclude that with the exception of Nimek and Biogesic all of the Nimesulide tablet brands investigated appear to have a high dissolution rate with extremely good bioavailability releasing gt45 percent Nimesulide within 30 minutes and thus satisfied the Indian Pharmacopoeia criterion for uncoated tablet dissolution. Auronim Zega Nise and Novogesic are interchangeable and bioequivalent.

Стандартизация и сравнительный анализ качества таблеток кислоты ацетилсалициловой

Currently, the pharmaceutical industry offers a fairly large number of acetylsalicylic acid (ASA) tablets. Relevant is their high quality, regardless of the manufacturer, the stability of indicators in the process of mass production. Objective: comparative analysis of the main quality indicators of ASA tablets of domestic pharmaceutical manufacturers, improvement of the test «Dissolution». Materials and methods. ASA uncoated tablets, 500 mg, 4 series from two pharmaceutical manufacturers. Evaluation of the quality of tablets and statistical processing of the results of a chemical experiment were carried out according to the relevant methods of the State Pharmacopoeia of the Russian Federation. Results. ASA tablets were standardized according to the following indicators: description, identity, mass uniformity of dosage forms, disintegration, abrasion, quantitative determination of the active substance, dissolution, impurities (salicylic acid). The dissolution profiles of ASA were studied depending on the dissolution medium. Compliance of all samples with the requirements of regulatory documentation was established. A unified test method "Dissolution" for ASA tablets is proposed. Conclusions. The identical composition of the excipients used, the high quality and pharmaceutical equivalence of ASA tablets of different production series and manufacturers have been established.

Stability Indicating Rp-Hplc Method Development and Validation for Simultaneous Quantification of Antihistaminic & Anti-Asthmatic Drug in Bulk and Tablet Dosage Form

The main aim of the present research work was to study Prospective process validation of Vildagliptin 50 mg uncoated tablet which is an Antidiabatic drug. Quality cannot be adequately assured by in- process and finished product testing but it should be built into the various stages of manufacturing process. The Process Validation was carried out for three consecutive batches manufacturing process, equipment, formula and validation criteria. The critical parameters involved in dry mixing, granulation, drying, Pre - lubrication, lubrication and compression stages, were identified, monitored and found in state of control. All the in process parameters and process variables were checked and found well within acceptance criteria. Loss on drying is not more than 2.5 % at 105 °C for 4 minutes by halogen moisture balance, Uniformity of Blend (By HPLC) was found within 10.0 % of the mean of the results and the % RSD not more than 5.0 %, Assay (By HPLC) for drug content is 47.5 mg to 52.5 mg was within the acceptable limit for the samples which were collected after lubrication stage (95.0 % to 105.0 %). The % LOD for dried granules after drying found out within 1.0 %w/w to 3.0 % w/w, In process testing for compression (Avg. wt. 20 Tab.: 194 mg to 206 mg; hardness 3.00-9.00 kg/cm2, thickness 2.95-3.55 mm; diameter 7.90-8.30 mm; friability NMT 1.0 % w/w; Disintegration time NMT 15 minutes and uniformity of dosage units found within acceptance value not more than 15.0 %).

Orally Disintegrating Tablet: A Review

Orally dispersive tablets are solid dosage forms that dissolve in the mouth in within 10 to 30 seconds, enabling waterless ingestion. The tablet dissolves quickly due to its fast breakdown, which also causes the effects to start acting quickly. ODTs can help patients with a variety of conditions, including paediatrics, geriatrics, psychosis, dysphagia, bedridden discomfort, comatose patients, young patients with undeveloped muscular and nervous systems, patients with hand tremors, and patients who travel often. It provides high stability, precise dosage, efficient manufacture, and smaller packing; self-administration is allowed on long journeys because water is not required. ODTs are a cost-effective way to distribute drugs. When a medicine is absorbed through the buccal cavity, ODTs constitute a critical drug delivery method. Spray drying, sublimation, and other scientific procedures like freeze drying, moulding, and direct compression. The availability of ODTs as over-the-counter drugs for the treatment of a range of illnesses is increasing. This article’s objective is to go over the benefits, drawbacks, formulation difficulties, manufacturing methods, patented technologies, commercially available formulations, and evaluation checks of ODT. The word “Oro dispersible tablets” was created by the European Pharmacopoeia. This is an uncoated tablet that dissolves easily in the mouth for 3 minutes before being swallowed.

Orally disintegrating tablet: A review

Orally dispersive tablets are solid dosage forms that dissolve in the mouth in within 10 to 30 seconds, enabling waterless ingestion. The tablet dissolves quickly due to its fast breakdown, which also causes the effects to start acting quickly. ODTs can help patients with a variety of conditions, including pediatrics, geriatrics, psychosis, dysphagia, bedridden discomfort, comatose patients, young patients with undeveloped muscular and nervous systems, patients with hand tremors, and patients who travel often. It provides high stability, precise dosage, efficient manufacture, and smaller packing; self-administration is allowed on long journeys because water is not required. ODTs are a cost-effective way to distribute drugs. When a medicine is absorbed through the buccal cavity, ODTs constitute a critical drug delivery method. Spray drying, sublimation, and other scientific procedures like freeze drying, moulding, and direct compression. . The availability of ODTs as over-the-counter drugs for the treatment of a range of illnesses is increasing. This article's objective is to go over the benefits, drawbacks, formulation difficulties, manufacturing methods, patented technologies, commercially available formulations, and evaluation checks of ODT. The word "Oro dispersible tablets" was created by the European Pharmacopoeia. This is an uncoated tablet that dissolves easily in the mouth for 3 minutes before being swallowed.

In vitro Pharmaceutical Quality Evaluation of different Ibuprofen tablet brands available on the Republic of Kosovo Market

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that possesses anti-inflammatory, analgesic, and antipyretic effects and it is widely manufactured and marketed in the Republic of Kosovo. The study aims to evaluate the in vitro quality of three ibuprofen uncoated tablets 400mg formulations that are commercially most commonly used in the Republic of Kosovo markets. Ibuprofen tablets were tested for the uniformity of weight, disintegration time, friability, and analysis of the drug active content with the UV spectrophotometric and high-performance liquid chromatography (HPLC) method following comparisons with official protocols and pharmacopeia monograph. The weight uniformity testing and weight variation indicated no significant changes in the weight and variation among the analyzed brands' tablets. The friability values were <1 % and the disintegration times were between 3.87 and 10.01 min, which showed significantly variation for the first brand but all the samples meet official requirements (within 15 min for uncoated tablets). In addition, the results of the assay of chemical content using UV-VIS and HPLC analysis meet the official specification in the UV and HPLC assay methods (95-105% of active drug content). Our data indicated that the Ibuprofen tablet investigated in our study meets the in vitro quality control meets the official specifications, is chemically equivalent, and does not vary in physiochemical qualities.

Formulation, Evaluation and Comparison of Mesalamine compression coated tablets by using Natural and Semi synthetic polymers

The main objective of this research paper is to formulate, evaluate and compare compression-coated tablets of Mesalamine using natural and synthetic polymer. The natural polymers used were pectin and Xanthan gum and the synthetic polymer used was HPMC E50 LV. Initially tablets were prepared by direct compression method using different polymers and both pre-compression and post-compression evaluation was conducted. Using the same polymers compression coated tablets of mesalamine were prepared by compression coating method using Cellulose acetate phthalate as the enteric polymer. These tablets were also subjected to pre-compression and post-compression evaluation and all the values obtained were in acceptable limits. Dissolution studies were conducted in different media having pH 1.2, 6.8 and 7.4. The dissolution results showed the drug release of uncoated tablet of HPMC E50 LV was 108.42% at 480 minutes, Pectin was 100.53% at 300 minutes and Xanthan gum was 108.73% at 90 minutes. The drug release of coated tablets of HPMC E50 LV was 100.42% at 680 minutes, Pectin was 102.31% at 580 minutes and Xanthan gum was 100.42% at 300 minutes. Hence the study showed that the compression coated tablets of mesalamine using HPMC E50 LV showed delayed release of the drug in 680 minutes.
 Keywords: Mesalamine, Colon targeting drug delivery system, Compression coating method, Delayed release, Cellulose acetate phthalate.

Risk Assessment and QbD-Based Optimization of Sorafenib Tosylate Colon Targeted Bilayer Tablet: In Vitro Characterization, In Vivo Pharmacokinetic, and In Vivo Roentgenography Studies.

The employment of site-specific administration in colon is a promising technique to improve efficacy and reduce systemic side effects of anticancer medications used in colorectal cancer. However, the physiology of the gastrointestinal tract and colonic environment limit the efficient delivery of orally administered anticancer drugs to the colon. These prerequisites can be fulfilled by a release modulated colon targeted drug delivery system (CTDDS) based on pH-dependent chronotherapeutic bilayer tablet of sorafenib tosylate (ST). Quality by design (QbD) was used to examine the risk assessment. The Box-Behnken design was used to optimize the core uncoated bilayer tablet, whereas the 22 factorial design was used to optimize the coating process. The amount of croscarmellose sodium, Eudragit® RLPO, and tablet hardness all had a significant impact on disintegration time and drug release, according to the results of the core uncoated bilayer optimization. The amount of Eudragit® S 100 and PEG 400 in the final coated tablet had a considerable impact on drug release. The optimized formulation demonstrated 5-h lag time, a peculiar feature of CTDDS. The pharmacokinetic studies of coated tablet in rabbits showed lower Cmax (4.45 ± 0.40µg/mL) and AUC (148.52 ± 3.96hµg/mL), whereas Tmax was substantially delayed (8.0 ± 0.57h) compared to core uncoated tablet. The tablet remained intact until it reached the colon (> 4h), according to the in vivo roentgenography studies. The present study revealed that a QbD approach can be useful to develop a rugged and scalable CTDDS.