Volume 8

April-June 2016

Review Articles

Mahalingan K, Mohd Nazish

Fast dissolving sublingual films is an emerging technology with rapid onset of action and improved patient compliance. It improves the efficacy of API’s and provides better drug utilisation. These formulations are suitable for cold, allergic rhinitis, asthma attacks, CNS disorders etc. where rapid onset of action is required for faster relief. The sublingual route of drug administration is very effective since, the drug absorbed through the sublingual blood vessels by passes hepatic first pass metabolic process and gives a better bioavailability. The present article overviews the materials used, formulation aspects, manufacturing methods, evaluation parameters and applications of fast dissolving films by sublingual route. Many patients find it difficult to swallow tablets and hard gelatin capsules particularly pediatric and geriatric patients and do not take their medicines as prescribed. Difficulty in swallowing or dysphasia is seen to afflict nearly 35% of the general population. In some cases such as motion sickness, sudden episode of allergic attack or coughing and an unavailability of water, the swallowing of tablet or capsules may become difficult, in such situation fast dissolving drug delivery system is alternative mode administering the drug.

Keywords: Sublingual Film, Fast Dissolving Film, Solvent Casting Method, Water Soluble Polymers, Ex Vivo Permeation Studies.

Kapoor D

Consumer demand of austerely processed foods without artificial preservatives has led to a growing attention in their substitution for new natural alternatives. The pressing issue to feed the escalating world population has twisted a demand to augment food production, which has to be cheaper, but at the same time must meet towering quality standards. Taste, appearance, texture, and microbiological safety are required to be preserved within a foodstuff for the longest period of time. Although substantial improvements have been met in terms of food additives, some are still enveloped in controversy. The lacks of uniformity in worldwide laws regarding additives, along with contradictory outcome of many studies help foster this controversy. In this report, the most important preservatives, nutritional additives, coloring, flavoring, texturizing, and miscellaneous agents are analyzed in terms of safety and toxicity. Natural additives and extracts, which are gaining interest due to changes in consumer habits are also evaluated in terms of their benefits to health and combined effects. Technologies, like edible coatings and films, which have helped overcome some drawbacks of additives, but still pose some disadvantages, are briefly addressed. Food preservative is a class of food additive that help to prevent food spoilage by preventing the growth and proliferation of pathogenic microorganisms like Clostridium spp, Bacillus cereus and Staphylococcus aureus. This can be achieved by bringing down the pH of the food so as to make the environment unfavorable for these microbes. Onion is widely used as a food ingredient and it is known as a good source of bioactive compounds, such as sulphur-containing compounds and flavonoids with well known health beneficial effects, antioxidant and antimicrobial capacities. Preservatives, whether natural or artificial, work as in three different ways: Antimicrobial, Antioxidants and Act on enzymes. In antimicrobial, the growth of microbes like bacteria and fungi is inhibited. In antioxidants the process of oxidation is either delayed or stopped. And the one that acts on enzymes stops the ripening or aging of food product. Preservation is important part in many industries, such as the cosmetic and pharmaceutical industries, as the shelf life of many cosmetic and pharmaceutical products is important. The present review is an extensive compilation of various preservatives obtained from plants, animal and microbial source.

Keywords: Additives, Preservatives, Microbiological Safety, Technologies, Food.

Research Articles

Hemal Tandel, Dhaval Shah, Jigar Vanza, Parva Jani, Ambikanandan Misra

The aim of this study was to formulate the microemulsion (ME) for nasal delivery of BCS Class-II drug Modafinil, used for the treatment of narcolepsy and attention deficit hyperactivity disorder (ADHD) optimized by ‘D-Optimal Mixture design’ and evaluation of its in-vitro and ex-vivo potential. Modafinil loaded mucoadhesive microemulsion (MME) was prepared with chitosan and concentration of chitosan was optimized by evaluating its stability after dilution, particle size and percentage transmittance. D-optimal mixture experimental design was applied to optimize microemulsion. The optimized batch revealed smaller droplet size (< 100nm), maximum % transmittance (>95% for 100 times diluted formulation) and was studied for stability for 3 months. The potential of chitosan loaded ME was compared to drug loaded ME system with a view to Permeation Coefficient and Diffusion Coefficient. The rate and extent of % drug diffusion was studied by using dialysis sac method, shows drug suspension had less release (39.658±0.964 %) as compared to drug loaded ME (53.6413±1.06 %) and MME (69.618±1.035 %) formulations in 4 hr. Ex-vivo study was performed using isolated tissue of the sheep nasal mucosa, approximately 50% drug released within 4 hrs, 2 hrs and 1.5hrs from drug suspension, drug loaded ME and MME respectively. The significant difference (p<0.05) was observed for in vitro and ex vivo drug release between ME, MME and drug suspension. Therefore MME can be used as a possible alternative dosage form of Modafinil to improve its therapeutic potential.

Keywords: Modafinil, Microemulsion, Mucoadhesive, Intranasal.

Shrishail M Ghurghure, Baburao N Chandakavathe

The aim of this research attempts was to improve the micrometric properties and solubility enhancement of spherically agglomerated crystals of Aceclofenac by using spherical agglomeration technique. The oral route of administration is the most important method of administering drugs for systemic effects. In this, the solid dosage form, particularly, tablets are the dosage form of a choice because of their special characteristics like unit dosage form with greatest dose precision and least content variability, lower cost, easy administration by a patient Aceclofenac is an orally effective non-steroidal anti-inflammatory drug (NSAID) of the phenyl acetic acid group which possesses remarkable anti-inflammatory, analgesic and antipyretic properties. Aceclofenac agglomerates were prepared with Poloxamer 188 and PEG 4000 using acetone-dichloromethane (DCM), water as the crystallization system. Various process variables such as selection of bridging liquid and good solvent, agitation speed, agitation time and mode of agitation of bridging liquid were optimized. The prepared aceclofenac spherical agglomerates were evaluated by micromeritic properties like optical microscopy, tapped density, bulk density, Carr’s index, drug content, and also carried out by FTIR, DSC, PXRD pattern, and Electron Scanning microscopy. The conclusion of this study was the agglomerates of Aceclofenac prepared with PEG 4000 and Poloxamer 188 showed improved solubility and dissolution in addition to improving the micromeritic properties. The solubility study reveals that the solubilizing efficiency of hydrophilic polymers enhances the drug solubility significantly as compare to plain agglomerates and Aceclofenac alone. The increase in drug release could be attributed to deposition of polymers on the recrystallized surface and better wettability of spherical agglomerates.

Keywords: Aceclofenac, DCM, PXRD, Spherical Agglomerates, Poloxamer 188.

Yogesh S Thorat, ‎Vipul L Pulli, ‎Avinash H ‎Hosmani, ‎Vivekanand G ‎Khyamgonde

The oral route is most popular route for the administration of therapeutic agents because of the low cost of therapy and ease of administration lead to high levels of patient compliance. In some cases such as motion sickness, sudden episode of allergic attack, fear of choking and an unavailability of water, the swallowing of tablet or capsules may become difficult. To overcome these difficulties, several fast dissolving drug delivery systems have been developed. Oral fast dissolving film (FDF) rapidly dissolves on tongue releasing the medication readily available for absorption. Domperidone is widely used as antiemetic drug It is also effective in gastro paresis, pediatric gastro esophageal reflux (infant vomiting). In the current work, Ocimum basilicum Gum was employed as a superdisintegrant to assist the flash dissolution of the film. The film was formulated on Film Forming machine by solvent casting method. HPMC was also incorporated in the film for enhancing the properties of the film. The prepared film was evaluated for different parameters. All the formulations of FDF displayed optimum folding endurance above 100 folds. The results were found to be promising ensuring safe and effective dosage form. From the result obtained, it was concluded that the formulation of fast dissolving film has better physical chemical properties with good dissolution property.

Keywords: Domperidone, Ocimum basilicum, Mannitol, Solvent Evaporation Technique.

Kumar N, Mahasweta Roy, Kumar B, Pooja Puri, Hasan M

Metformin HCl matrix tablets were formulated and evaluated using different drug polymer (pectin/alginate) by direct compression method. The blends were evaluated for pre-compression and post-compression studies including swelling & erosion studies. In vitro release studies were carried out in acidic buffer (pH 1.2) and phosphate buffer (pH 6.8). The drug release was found to decrease with increase in the amount of polymer added in each formulation. Release studies also showed that the swelling and erosion of matrix tablets influenced the drug release and a bi-phasic release with an initial burst effect was observed with matrix tablets. The percent cumulative drug release was found to be sustained for all formulations and best formulation was A3 with 94.16% drug release in 11 hr. The kinetic studies revealed that the three formulations were good fitted into Korsmeyer-Peppas and six formulations were good fitted in Higuchi matrix model.

Keywords: Pectin, Sodium Alginate, Metformin HCl, Matrix Tablet, Drug Release, Swelling, Erosion, Cumulative Drug Release Kinetic, Formulations.

Instructions to Authors
Subscription and Advertisement Forms