Purpose: The purpose of the study was to develop and optimize rosiglitazone maleate mucoadhesive extended-release tablets by quality by design (QbD) approach. Based on QTPP (quality target product profile) CQAs (critical quality attributes) were identified. Methods: Failure mode and effects analysis (FMEA) method were adopted for risk assessment. Risk analysis by the evaluation of formulation and process parameters showed that the optimizing the levels of polymers could reduce high risk to achieve target profile. Drug-excipient compatibility studies by Fourier transforms infra-red and DSC studies showed that the drug was compatible with the polymers used. Design of experiment (DoE) performed by Sigma tech software, Carbopol 934P and sodium carboxymethyl cellulose (SCMC) were identified as independent variables and hardness, drug release at 12 hours and ex vivo mucoadhesion time were adopted as responses. Contour plots generated from the software were used for identification of design space. Results: Carbopol 934P and SCMC had positive and negative effects respectively on the selected responses. Higher the concentration of Carbopol 934P and lower the concentration of SCMC mucoadhesive extended release criteria could be achieved. Drug release kinetics followed first order release with Higuchi diffusion and Fickian diffusion. Ex vivo mucoadhesion test on goat stomach mucosa indicated that adhesion time increased at higher concentrations of Carbopol 934P. Optimized formula satisfying all the required parameters was selected and evaluated. The predicted response values were in close agreement with experimental response values, confirmed by calculating standard error. Conclusion: It has been concluded that the application of QbD in the optimization reduced the number of trials to produce a cost-effective formula.

In India, awareness about menstruation before menarche was low, and it is viewed as unclean or dirty in society. In adolescent girls who attained menstruation for the first time, menstrual hygiene management is constrained by social, practical and economic factors such as the expense of sanitary pads, lack of water facilities, lack of private rooms for changing sanitary pads, and limited education about the facts of menstrual hygiene. The practice of good menstrual hygiene reduces the incidence of reproductive tract infections. The aim of the present study was to assess the impact of pharmacist mediated educational program on menstrual hygiene practice. An interventional study was carried out to assess the impact of menstrual hygiene practice on knowledge and practice of menstrual hygiene among adolescent girls in backward areas of Andhra Pradesh, India. A self-administered questionnaire comprises socio-demographic characteristics, knowledge related to menstruation and menstrual hygiene practice was used to collect data. The collected data was analyzed to assess the knowledge related to the menstrual hygiene practice, school attendance during the menstrual period at baseline and after providing education on menstrual hygiene. The present study reveals that 52.52% of the participants had good knowledge about menstrual hygiene. Pharmacist mediated educational program showed great improvement on the practice of menstrual hygiene such as the use of sanitary pads was improved from 40.42% to 93.38%. After educational program school dropouts was greatly declined from 55.32% to 7.33%. Pharmacist mediated program had a positive impact on menstrual hygiene practice, Government of India need to conduct more educational programs on menstrual hygiene management at a community level.

Objective: The present work was designed to formulate and optimize Orodispersible tablets of Piroxicam using QbD approach. The central composite design tool was used to evaluate the scientific understanding of input and output variables to construct design space for regulatory flexibility. Methodology: The concentrations of super disintegrants were selected as independent variables. The dependent variables selected were in vitro dispersion time and percentage drug release. The quantitative effect of independent variables at different levels on response variables was predicted using polynomial equations. The model was found to be nonlinear and the curvature effect was significant. Therefore study resorted to composite design for optimization. Results and Discussion: DSC studies indicated drug and excipients were compatible. Precompression para meters indicated fairly good flow properties. Tablets were prepared by direct compression method and all the tablets prepared in the above studies were evaluated for pharmacotechnical properties and were found to be within specified limits. Increase in the concentration of Sodium starch glycolate (SSG), Crospovidone (CP) decreased the in vitro dispersion time and increased percentage drug release. Kinetic studies revealed that drug release from all formulations followed first order release. The relationship between independent variables and dependent variables was further elucidated using contour plots. Based on these plots most economical batch was decided which were in desired range. This is an open access article distributed under the terms of the Creative Commons AttributionNonCommercialShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work noncommercially, as long as the author is credited and the new creations are licensed under the identical terms.

In the last decade, nanosuspensions have gained considerable interest as a method for formulating poorly soluble drugs. Because of their cost-effectiveness and technological simplicity compared to liposomes and other colloidal drug carriers, nanoscale systems have recently received a lot of attention as a way of solving problems of solubility. Nanosuspensions are biphasic systems comprising of pure drug particles dispersed in an aqueous vehicle, stabilized by surface active agents. Fabrication of nanosuspension is simple and more advantageous than other approaches. Nanosuspension is a very finely single solid drug particle in an aqueous vessel, stabilized by surfactants for either oral or topical use or for parenteral and pulmonary administration, it can also be used for targeted drug delivery when incorporated in the ocular inserts and mucoadhesive hydrogels, with reduced particle size resulting in increased dissolution rate. This article covers the preparation of nanosuspension by bottom up technology, top down technology, melt emulsification, emulsification- solvent evaporation and supercritical fluid with their advantages and disadvantages, aspects of structure, classification and their drug delivery applications. Nanosuspension can be processed for the drugs which are of hydrophobic in nature quite easily employing stability enhancers, solvents that are of organic and additional ingredients including buffering agents, salts, PEG, osmotic agents and anti-freeze compounds.

The objective of this review is to explore the past work done on Cubosomes as drug delivery systems by factorial design. Cubosomes are Nanoparticulate systems made of amphiphilic lipids at a certain percentage, known as liquid crystals. They have tightly packed honeycomb structures twisted into 3D bilayers. Cubosomes can capture all categories of the lipophilic, hydrophilic, and amphiphilic substances irrespective of their affinity, by that they fit for delivering all range of drugs with ease. Many works in recent days are concentrating on Cubosomes for drug delivery, as it suits all ranges of drugs without much difficulty. Cubosomes acts as a carrier in drug delivery for a wide range of drugs and protects them from degradation issues like hydrolysis, oxidation, and others. Moreover, numerous studies have established the benefits of Cubosomes in nanotechnology, prolonged-release, and also enhanced bioavailability. This article reviews about the past work done on Cubosomes using factorial design. Additionally, many studies need to be performed for the optimization of Cubosomes for artificial cells, and biosensors, etc. Moreover, the rational design of Cubosomes for biomedical applications need to be developed. A widespread literature assessment revealed that many reviews and research attempts were made on Cubosomes, but no review article is still available in bringing the attempts made on Cubosomes by factorial design on a single platform. The factorial approach is used to optimize the formulation, which is acceptable and used in the current scenario in optimizing the formulations. So, the authors made widespread work by referring to peer-review journals, periodicals, magazines, and succeeded in bringing work done on Cubosomes in the last ten years by using factorial design. The study concludes and gives a quick reference to the young researchers to get literature on earlier successive attempts done on Cubosomes by factorial design.

Objectives:The present work was designed to formulate extended-release tablets of clarithromycin by means of central composite design. To assess the systematic considerate of input and output variables and to construct design space, the central composited design was used. Methods: The concentrations of tamarind kernel powder (X 1 ), ethyl cellulose (X 2 ) and polyvinyl pyrrolidone (X 3 ) remained as independent variables and responses were drug release in 2 h, 8 h and t50%. Polynomial equations were employed to forecast the quantitative result of nondependent constraints at different levels on responses. The model stood nonlinear and the curvature outcome was significant.Henceforth the study employed central composite design for optimization. Wet granulation method was used to prepare the tablets and were evaluated for pharmacotechnical properties. Results: FTIR and DSC studies signposted that drug and excipients were compatible. Precompression constraints specified respectable flow properties. The in vitro drug release of entire formulations at the end of 12 h was found to be 96.14% -98.23%. Increase in the concentration of tamarind kernel powder, ethyl cellulose decreased percentage drug release. Contour plots were utilized to assess the relationship between independent variables and dependent variables. Conclusion: The statistical model is scientifically effective as the investigational estimates and foreseen estimates proposed by the model were relatively close to each other. The outcomes confirmed the success of the anticipated design for development of clarithromycin extended-release tablets with optimized properties.

Objectives: The purpose of the work was to develop gastro retentive floating tablets of Dicloxacillin sodium using different ratios of HPMC K 100M, Xanthan gum, Guar gum. Sodium bicarbonate is used as a gas generating agent. Dicloxacillin sodium is used to treat a wide variety of bacterial infections and has a half-life of about 2 hr. Methods: Gastro retentive floating tablets containing 270 mg of dicloxacillin sodium were prepared by wet granulation method employing different ratios of polymers. Results: The formulated tablets were evaluated for precompression parameters and were in the acceptable limits. Post-compression parameters such as weight variation, hardness, friability, swelling index, floating lag time and total floating time were also evaluated. The formulation F3 with HPMC K 100M showed 98.87% of drug release at the end of 12 hr, maintained integrity of tablets and have an optimum floating lag time of 90±0.14 sec and total floating time of 12 hr. The optimized formulation F3 was fitted to various kinetic models and the results showed that F3 formulation followed Zero order kinetics with an R 2 value of 0.993. The mechanism of drug release from F3 formulation was non-fickian diffusion. Conclusion: The study concluded that, among all the developed formulations, F3 formulation floated up to 12 hr with maximum drug release and can be considered as promising formulation.

Background The present study was aimed to enhance the solubility and dissolution of BCS class II drug, telmisartan (TEM), by nanoformulation approach. Several attempts were made to develop a nanosuspension by bottom-up and top-down techniques. In our study, we found in situ nanoamorphization technique to be incompatible and hence was not selected for further development of nanoformulation. Bottom-up techniques such as anti-solvent precipitation and emulsification solvent evaporation methods failed to reduce the size of the drug to nanoform by HPMC E15 and PVP K-25 at 1500–2000 rpm but resulted in micron-sized particles. Results However, the acid-base neutralization method has produced nanosuspension with a particle size of 243.9 nm and 0.119 PDI. Formulation and analytical development were carried out by statistical factorial design using the Design-Expert software (version 11.0). The nanosuspensions remained stable even after 90 days without any aggregations with particle size 338.1 nm and PDI 0.146. Zeta potential of optimized formulation was found to be − 16.2 mV. Drug content and its release were estimated by the developed and validated in-house HPLC method. In vitro drug diffusion studies on the optimized formulation have shown a drug release of 82.6% by the end of 3 h, whereas plain drug suspension has shown only 42.8% release, indicating a 2-fold increase of drug diffusion with nanosuspension. Ex vivo drug permeation studies performed using excised goat gastric mucosa revealed much faster permeation of TEM from nanosuspension than the plain drug suspension. Conclusions Hence, from the results, it can be concluded that TEM, when formulated by acid-base neutralization method as a nanosuspension, leads to enhanced solubility, dissolution, and stability.