CHEWING GUM: CONFECTIONARY TO A POPULAR TRANSBUCCAL DOSAGE FORM

Chewing gum is a highly convenient and controlled release transbuccal drug delivery system taken without water. It is gaining popularity as a selfadministrable carrier for the medication used for motion sickness, smoke cessation, hypertension, xerostomia, dental caries, pain, as nutritive and energy supplements. Functional chewing gum favors both local and systemic effects intended to be chewed about half an hour. It has emerged out with a fast onset of action either by direct absorption or swallowed with saliva into gastrointestinal tract.It has better bioavailability that lowers the doses and reduces the gastric side-effects. Gums adhere with ease and compliance of administration to children and dysphagia patients. Chewing gums are formulated using a water-insoluble gum base with water-soluble excipients with the active ingredient in the case of medicated gums. European Pharmacopeia standards used for release studies, there are no other particular official standards. It has attracted the researchers as successful potential drug delivery system in coming future. The present article reviews it as novel drug delivery system including its merits and limitations, material and methods of formulation and evaluation

Preparation and Evaluation of Novel In Situ

The objective of this work was to develop an oral mucosal drug delivery system to facilitate the local and systemic delivery of acyclovir for the treatment of oral herpes infection caused by the herpes simplex virus (HSV). An in situ gelling system was used to increase the residence time and thus the bioavailability of acyclovir in oral mucosa. Temperature and pH trigged in situ gel formulations were prepared by cold method using polymers like poloxamer 407, carbopol 934, and HPMC. Glycerin and a mixture of tween 80 and ethanol (1 : 2 ratio) were used as the drug dissolving solvent. The pH of carbopol containing formulation was adjusted to pH 5.8 while the pH of poloxamer solution was adjusted to pH 7. These formulations were evaluated for sol-gel transition temperature, gelling capacity, pH, viscosity, spreadability, gel strength, drug content, ex-vitro permeation, and mucoadhesion. The gelation temperatures of all the formulations were within the range of 28–38°C. All the formulations exhibited fairly uniform drug content (98.15–99.75%). Drug release study of all the formulations showed sustained release properties. The release of drug through these in situ gel formulations followed the Higuchi model and Korsmeyer peppas model mechanism

APPLICATION OF QUALITY BY DESIGN APPROACH FOR THE OPTIMIZATION OF ORODISPERSIBLE FILM FORMULATION

Objective: The present study was done to understand the effect of formulation variables on the quality of orodispersible films using quality by design (QbD) approach as mentioned in ICH Q8 (R2) guideline.Methods: A definitive screening design of experiments (DoE) was used to identify and classify the critical formulation variables affecting critical quality attributes (CQA) using 2×2 factorial design. Based on prescreening study, the critical formulation variables, i.e. concentration of film-forming polymer and plasticizers (propylene glycol and polyethylene glycol 400 [PEG 400]) were kept in the range of 1.5–2.5% w/w and 0.5–1% v/v, respectively. A total of eight laboratory-scale formulations were prepared which were provided by DoE using solvent casting method. These batches were evaluated for CQA's, i.e. mechanical properties such as folding endurance (FD) and disintegration time (DT). Data were analyzed for elucidating interactions between two variables and for providing a predictive model for the process. Finally, the drug was incorporated into optimized batches, and these were evaluated for in vitro dissolution study in simulated saliva (pH 6.8) as well as their mechanical properties.Results: The results suggested that the concentration of film-forming polymer and plasticizer was critical to manufacture orodispersible film with desired CQA, i.e. mechanical property (FD [>150 folds]) and DT (<60 s). The percent drug release, FD, and DT of optimized Formulation I (hydroxypropyl methylcellulose [HPMC] E5 (2%) and propylene glycol [0.15 mL]) were found to be 82.13%±0.260 (in 15 min), 164±2, and 49±1.5 s, respectively, and for optimized Formulation II (HPMC E5 [2%] and PEG 400 [0.15 mL]) was found to be 64.26%±2.026 (in 15 min) and 218±6 and 55±4 s, respectively.Conclusion: From the results, it has been found that the percentage drug release of naratriptan hydrochloride containing propylene glycol as a plasticizer was greater than the formulation containing PEG 400 as plasticizer. From this, we concluded that QbD is very much useful approach to get an optimized formulation in an economic and faster way in comparison to traditional method (hit and trail methods). The futuristic application of the film will involve the management of an acute migraine

Validated, Ultra Violet Spectroscopy Method for the Dissolution Study of Mycophenolate Mofetil Immediate Release 500mg Tablets

A simple, selective and precise dissolution method was developed and validated for the Mycophenolate mofetil immediate release tablets. The method employed dissolution medium 0.1N HCl (pH1.2) and volume 900ml with USP-II apparatus (Paddle). Detection was made by measuring the absorbance on UV at the λ~max~ 250nm. The method show the linearity in the range of conc. 5[mu]g/ml to 40[mu]g/ml with r^2^=0.999. The method is also validated as per International Conference of Harmonization guidelines. The method showed the specificity with standard deviation 0.00. The method is repeatable, selective and accurate for the dissolution study of Mycophenolate mofetil immediate release tablets

Preparation and evaluation of novel in situ gels containing acyclovir for the treatment of oral herpes simplex virus infections. Scientific World Journal. 2014;2014:280928. International Journal of Nanomedicine Publish your work in this journal Submit you

The objective of this work was to develop an oral mucosal drug delivery system to facilitate the local and systemic delivery of acyclovir for the treatment of oral herpes infection caused by the herpes simplex virus (HSV). An in situ gelling system was used to increase the residence time and thus the bioavailability of acyclovir in oral mucosa. Temperature and pH trigged in situ gel formulations were prepared by cold method using polymers like poloxamer 407, carbopol 934, and HPMC. Glycerin and a mixture of tween 80 and ethanol (1 : 2 ratio) were used as the drug dissolving solvent. The pH of carbopol containing formulation was adjusted to pH 5.8 while the pH of poloxamer solution was adjusted to pH 7. These formulations were evaluated for sol-gel transition temperature, gelling capacity, pH, viscosity, spreadability, gel strength, drug content, ex-vitro permeation, and mucoadhesion. The gelation temperatures of all the formulations were within the range of 28-38 ∘ C. All the formulations exhibited fairly uniform drug content (98.15-99.75%). Drug release study of all the formulations showed sustained release properties. The release of drug through these in situ gel formulations followed the Higuchi model and Korsmeyer peppas model mechanism

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LEVOSULPIRIDE AND RABEPRAZOLE SODIUM: A NEW ANALYTICAL Q-ABSORBANCE RATIO APPROACH

Objective: The aim of the study was to develop a precise, accurate, and rapid ultraviolet spectrophotometric method for simultaneous estimation of levosulpiride (LEVO) and rabeprazole sodium (RBS) in the binary mixture and to validate the method as per ICH guidelines.Method: Estimation of LEVO and RBS was performed by Q-absorbance method. Analysis was performed using the ratio of absorbance at two selected wavelengths, one at iso-absorptive point and other is the absorbance maxima of any one of the components. Single scan spectrum and the overlain spectrum conclude that absorbance maxima of LEVO and RBS are 228 and 291.8 nm, respectively, with a coinciding iso-absorptive point at 255 nm. Method uses a ratio of absorbance for assay at 255 and the second wavelength is 291.8 nm, λmax for RBS. It is also applicable at 228 nm, as the second wavelength.Results: Linearity of LEVO and RBS was found to be 25-125 and 4-36 μg/ml, respectively. The accuracy of the LEVO and RBS was found 99.26% and 99.51%, respectively and Sandell's sensitivity ranged between 0.0238 and 0.594 μg/cm2. Assay of LEVO (75 mg) and RBS (20 mg) in capsule dosage form was found 99.5% and 98.69% w/w, respectively.Conclusions: The developed method for the estimation of LEVO and RBS in binary mixture were found to be simple, accurate, robust, and reproducible. No interference of excipients and the degraded product was found during the estimation. Therefore, the method can be successfully applied for routine quality control analysis.RBS) in the binary mixture and to validate the method as per ICH guidelines.Method:  Estimation of LEVO and RBS was performed by Q-absorbance method. Analysis was performed using the ratio of absorbance at two selected wavelengths, one at iso-absorptive point and other is the absorbance maxima of any one of the components. Single scan spectrum and the overlain spectrum conclude that absorbance maxima of LEVO and RBS are 228 and 291.8 nm respectively with a coinciding iso-absorptive point at 255 nm. Method uses ratio of absorbance for assay at 255 and the second wavelength is 291.8 nm, λmax for RBS. It is also applicable at 228 nm, as the second wavelength.Results: Linearity of LEVO and RBS were found to be 25-125and 4-36 μg/ml respectively. Accuracy of the LEVO and RBS was found 99.26 and 99.51% respectively and Sandell's sensitivity ranged between 0.0238 and 0.594 ðœ‡g/cm2. Assay of LEVO (75 mg) and RBS (20 mg) in capsule dosage form was found 99.5 and 98.69% w/w respectively.Conclusions: The developed method for the estimation of LEVO and RBS in binary mixture were found to be simple, accurate, robust and reproducible. No interference of excipients and the degraded product were found during the estimation. Therefore the method can be successfully applied for routine quality control analysis

Nanoformulations of quercetin: a potential phytochemical for the treatment of uv radiation induced skin damages

The continuous prolonged exposures of sun light especially the ultra violet (UV) radiation present in it, cause not only the risk of skin cancer but also it may cause premature skin aging, photodermatoses and actinic keratoses. Flavonoids (including Flavane, Flavanone, Flavone, Flavonol, Isoflavone, Neoflavone etc.) having potent antioxidant activity, used as topical applications for protection against UV induced skin damages as well as for skin care. Most commonly used flavonoid is quercetin (Flavonol), which is present in fruits, vegetables, and herbs. We aim to review the research focused on development of different novel formulations to treat UV radiations induced skin diseases. In this review, several formulations of flavonoid quercetin were discussed and their outcomes were compiled and compared in context to solubility, stability and efficiency of application. On the basis this comparative analysis we have concluded that three formulations, namely glycerosomes, nanostructured lipid carriers and deformable liposomes hold good applications for future aspects for topical delivery of quercetin. These formulations showed enhanced stability, increased quercetin accumulation in different skin layers, facilitated drug permeation in skin and long-lasting drug release