Lyophilized Composite Loaded with Meloxicam-Peppermint Oil Nanoemulsion for Periodontal Pain

Maintaining oral health helps to prevent periodontal inflammation and pain, which can progress into more detrimental issues if left untreated. Meloxicam (MX) is a commonly used analgesic for periodontal pain, but it can have adverse gastrointestinal effects and poor solubility. Therefore, this study aimed to enhance the solubility of MX by developing a self-nanoemulsifying drug delivery system (SNEDDS). Considering the anti-ulcer activity of peppermint oil (PO), it was added in a mixture with medium-chain triglyceride (MCT) to the MX-loaded SNEDDS formulation (MX-PO-SNEDDS). After optimization, MX-PO-SNEDDS exhibited a PO:MCT ratio of 1.78:1, surfactant mixture HLB value of 14, and MX:oil mix ratio of 1:15, a particle size of 47 ± 3 nm, stability index of 85 ± 4%, ex vivo Jss of 4 ± 0.6 μg/cm2min, and ulcer index of 1 ± 0.25 %. Then, orally flash disintegrating lyophilized composites (MX-SNELCs) were prepared using the optimized MX-PO-SNEDDs. Results reveal that MX-SNELCs had a wetting time of 4 ± 1 s and disintegration time of 3 ± 1 s with a high in vitro MX release of 91% by the end of 60 min. The results of pharmacokinetic studies in human volunteers further demonstrated that, compared to a marketed MX tablets, MX-SNELCs provided a higher Cmax, Tmax, and AUC and a relatively greater bioavailability of 152.97 %. The successfully developed MX-SNELCs were found to be a better alternative than the conventional tablet dosage form, thus indicating their potential for further development in a clinically acceptable strategy for managing periodontal pain.

Development of an Age-Appropriate Mini Orally Disintegrating Carvedilol Tablet with Paediatric Biopharmaceutical Considerations

Owing to considerable differences observed in anatomy and physiology between paediatric subsets, it has been well established that children respond to drugs differently compared to adults. Furthermore, from a formulation perspective, there is a distinct challenge to develop a dosage form that is capable of safely, accurately, and reliably delivering the dose across the whole paediatric population. Orally disintegrating mini-tablets (ODMT) have widely been considered as an age-appropriate formulation option that possess the ability for adequate dose flexibility, avoids swallowing difficulties, and exhibits superior stability due to its solid state. Within this study, two strengths (0.5 mg and 2 mg) of carvedilol ODMT formulations were developed using an excipient composition and load that is appropriate for paediatric use. The formulations demonstrated adequate mechanical strength (>20 N) and fast disintegration times (<30 s). Dissolution profiles observed were robust and comparable to the marketed conventional tablet formulation across various parts of the gastrointestinal (GI) tract in both the fed and fasted state, signifying appropriate efficacy, quality, and performance. As such, the formulations developed in this study show potential to address the need of an ‘age-appropriate’ formulation of carvedilol, as highlighted by the European Medicines Agency (EMA) Inventory of the Needs for Paediatric Medicine.

Development of Nifedipine sublingual tablets using disintegrants as release modifiers

The current study mainly focused on treating cardiovascular diseases such as angina pectoris and chronic hypertension by modifying the existing commercial tablet available for Nifedipine. The limitation of Nifedipine is poor solubility, which comes under BCS class II drug category, which needs improvement in formulation to achieve better bioavailability. The objective of this research work is to enhance the oral bioavailability (first-pass metabolism in the liver (42–56%)) of Nifedipine by improving dissolution property. Sublingual fast dissolving tablets of Nifedipine formulated by sublimation method, designed to increase its disintegration time in the presence of saliva. This formulation is helpful for paediatric and geriatric patients who are unable to swallow the conventional tablet. Sublimation of camphor makes the tablet more porous and improve disintegration time as well. The direct compression method is used with different ratio of Croscarmellose Sodium (CS) and Sodium Starch Glycolate (SSG) as super disintegrants to formulate Nifedipine loaded Sublingual tablets. All formulations contain various ratio between super disintegrants and camphor, followed by the sublimation method. FTIR and DSC studies were conducted to investigate compatibility between drugs and disintegrants. Formulated tablets were subjected for precompression parameters, e.g., bulk density, tapped density, Carr’s index, Hausner’s ratio, angle of repose and for post-compression parameters, e.g. weight variation, thickness, hardness, friability, drug content, wetting time, disintegration time followed by dissolution study and found satisfactory as per IP.

COMPARATIVE QUALITY EVALUATION OF TWO BRANDS OF PARACETAMOL TABLETS OBTAINED FROM THE MARKET

Introduction: Paracetamol tablets are very common over the counter (OTC) products among the patients as a good analgesics s. It is the drug of choice in patients that cannot be treated with non-steroidal anti-inflammatory drugs (NSAID), such as people with bronchial asthma, peptic ulcer disease, hemophilia, salicylate-sensitized people and children under 12 years of age, pregnant or breastfeeding women. Objective: The objective of this study was to compare the quality of the paracetamol tablet formulations those are locally available in India pharmaceutical market manufactured by various pharmaceutical companies with pharmacopeia standards. Materials and Methods: The two popular brands (A & B) of paracetamol conventional tablet of 500 mg strength were chosen. The paracetamol tablets were obtained from the local medical shops. To compare the quality of tablet formulations of different brands various official parameters like friability, hardness, weight variation, disintegration time and dissolution were performed as per the standards mentioned in pharmacopoeia. Result and Conclusion: The result of all these parameters of different brands was in the Pharmacopoeial limits so it could be concluded that marketed pharmaceutical tablets of paracetamol of these brands are safe, effective and efficacious.

Novel Co-processed Spray Dried Super Disintegrants Designing of Fast Dissolving Tablets Using

In the present study, novel co-processed superdisintegrants were developed by spray drying method using microcrystalline cellulose and mannitol in different ratios (1:1, 1:2 and 1:3) for use in the fast dissolving tablet formulations. The developed excipients were evaluated for angle of repose, Carr’s index and Hausner’s ratio in comparison with physical mixture of superdisintegrants. The angle of repose of the developed excipients was found to be < 30o, Carr’s index in the range of 9-15 % and Hausner’s ratio in the range of 1.12-1.16. Fast dissolving tablets of glibenclamide were prepared using the above co-processed superdisintegrants and evaluated for pre-compression and post-compression parameters. Based on in vitro dispersion time (approximately 22.23 sec), promising formulation MCM3 was tested for in vitro drug release pattern in pH 6.8 phosphate buffer and stability (at 400C/75 % RH for 3 months), drug excipients interaction (IR spectroscopy) were studied. Among the designed formulations, the formulation (MCM3) containing 8 % w/w of co-processed superdisintegrant (1:3 mixture of microcrystalline cellulose and mannitol) emerged as the overall best formulation (t50% 1.6 min) based on drug release characteristics in pH 6.8 phosphate buffer compared to commercial conventional tablet formulation (t50% 6 min). Stability studies on promising formulation indicated that there were no significant changes in drug content and in vitro dispersion time (p<0.05).Dhaka Univ. J. Pharm. Sci. 15(2): 167-172, 2016 (December)

Review: ODT’s drug containing Spironolactone

Orally disintegrating tablets (ODTs) have emerged as one of the popular and widely accepted dosage forms, especially for the pediatric and geriatric patients. To obviate the problem of dysphagia and to improve patient compliance, ODTs have gained considerable attention as preferred alternatives to conventional tablet and capsule formulations In the present study, an attempt has been made to prepare orally disintegrating tablet of the drug Spironolactone using superdisintegrants crosspovidone, crosscarmellose sodium and sodium starch glycolate by direct compression technique. Various scientific techniques including freeze drying, moulding, spray drying, sublimation, direct compression, cotton candy process, mass extrusion, melt granulation etc. have been employed for the development of ODTs. The prepared tablets were evaluated for pre and post compression parameters i.e. angle of repose, car’s index, hausner’s ratio, hardness, friability, wetting time, weight variation, in vitro disintegration and in vitro dissolution study.

Fast Dissolving Oral Films: A Novel Trend to Oral Drug Delivery System

Oral routes are most commonly preferred route for delivering drug. Most common oral dosage forms are tablet and capsules. But many patients such as geriatric, pediatric and dysphasic patients find difficult to swallow conventional tablet and capsule. To overcome various problems related to swallowing, Fast dissolving Tablets (FDTs) were designed in early 19th century and hence further advancement has led to development of Fast Dissolving Oral Films (FDOFs). In the recent years, many of the pharmaceutical groups are focusing their research on rapid dissolving technology. Amongst the plethora of avenues explored for rapid drug releasing product, FDOFs technology is gaining much attention. These are solid dosage forms, which disintegrate or dissolve within 1 min when placed in the mouth without drinking water or mastication. This technology has been used for local action as well as rapid release products. The fast dissolving oral films are formulated using various Active pharmaceutical ingredients (API), film forming polymers, plasticizer, flavors, colors and sweeteners. Initially FDOFs are up to breath strips, confection and oral care markets. But now it became a novel and widely accepted technology for delivering OTC and prescription medication too.Sunsari Technical College Journal 2015, 2(1):58-68