Examining a huge amount of data is a typical issue in any research process. However, different statistical processes and techniques play essential role to derive a meaningful conclusion from the presented enormous data. Control of type I error is highly essential for a researcher or statistician while dealing with comparisons test with more than two variables. Multiple testing statistical tests provides a structural system and minimizes the error rate by helping to derive meaningful accurate conclusions. Among the different multiple test procedures Tukey's honestly significant difference test (Tukey's HSD) is most common and popular techniques. The main objective of this study was to explore how significantly selection of confidence level or error rate can affect the rate of committing type I error while drawing conclusion. The effect of committing type I error with selection of confidence level or error rate was explored with citing suitable case study in a special education setting. The case study focuses cognitive effect of music on growth and enhancement of the motor behavior (running, jumping and sliding) of children with mild intellectual disability enrolled in the special school setting. ANOVA test was performed and the significance of selection of individual confidence level and simultaneous confidence level) in Tukey's HSD test was described.

Solid dispersions (SDs) and physical mixtures (PMs) of valsartan in β-cyclodextrin (β-CD), hydroxypropyl β-cyclodextrin (HP β-CD), and polyvinyl pyrollidone (PVP K-30) were prepared to increase its solubility characteristics. The drug formulations were characterized in the solid state by Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC). By these physical determinations, drug-polymer interactions were found. Both the solubility and the dissolution rate of the drug in these formulations were increased. Drug contents were determined by UV spectrophotometry at a λ max of 249.5 nm. The phase solubility behavior of valsartan in various concentrations of β-CD, HP β-CD, and PVP K-30 (0.25-1.0% w/v) in distilled water was obtained at 37 ± 2 °C. The dissolution of valsartan is increased with increasing amounts of the hydrophilic carriers (i.e., β-CD, HP β-CD, and PVP K-30). Gibbs free energy (ΔG o tr ) values were all negative, indicating the spontaneous nature of valsartan solubilization. The SDs of valsartan with β-CD and HP β-CD were prepared at 1:1, 1:3, and 1:5 drug/carrier ratios by a kneading method, and PVP K-30 SDs were prepared at the same ratios (i.e., 1:1, 1:3 and 1:5 drug/carrier) by a lyophilization technique. The FTIR spectroscopic studies show the stability of valsartan and the absence of well-defined drug-polymer interaction. Compared with β-CD, HP β-CD showed better enhancement of dissolution rate; compared with HP β-CD, PVP K-30 showed better solubility and dissolution enhancement.

The main objective of the present study is to present the concept of process capability and to focus its significance in pharmaceutical industries. From a practical view point, the control charts (such as X and R hart) sometimes are not convenient summary statistics when hundreds of characteristics in a plant or supply base are considered. In many situations, capability indices can be used to relate the process parameters. The resulting indices are unit less and provide a common, easily understood language for quantifying the performance of a process. Process capability indices (PCIs) are powerful means of studying the process ability for manufacturing a product that meets specifications. Several capability indices including Cp, Cpu, Cpl and Cpk have been widely used in manufacturing industry to provide common quantitative measures on process potential and performance. The formulas for these indices are easily understood and can be directly implemented. A process capability analysis compares the distribution of output from an in-control process to its specifications limits to determine the consistency with which the specifications can be met. The process capability is also having a significant role in pharmaceutical industry. Process capability indices can be a powerful tool by which to ensure drug product quality and process robustness. Determining process capability provides far more insight into any pharmaceutical process performance than simply computing the percentage of batches that pass or fail each year. Keywords: Process capability; Cp/Cpk; Pp/Ppk; Pharmaceutical quality, process robustness, specification

Background The main objective of the present study was to develop and optimize an effervescent tablet of levetiracetam, an antiepileptic drug, using central composite design with response surface methodology (RSM).The present investigation helps to overcome the problem associated with levetiracetam tablets and liquid dosage forms with children and elderly people like bad taste and swallowing difficulties. It also facilitates as an alternative manufacturing process for advanced patented technology like 3D printing process employed in SPRITAM® tablet. Levetiracetam effervescent tablets were prepared by dry granulation (roll compaction) method using water-soluble excipients and optimized by central composite rotatable design (CCRD) using two variables (citric acid and effersoda) at two levels (high and low). Overall, fourteen formulation trials were generated through statistical software Minitab 17.3.0 placing 6 center points, 4 cube points, and 4 axial points. All formulations were subjected to compression using single punch machine. Results Quality attributes of compressed tablets were evaluated using various compendial and non-compendial tests. RSM was used to observe the responses like effervescent time, hardness, and friability of the prepared tablet batches for different levels of all the variables. Polynomial equations were developed, and model plots (contour plot and 3-dimensional model surface plots) were generated to study the impact of acid-base couple on the responses. Finally, the optimized formulation was selected on the basis of desired effervescent time, hardness, friability, percent drug release, and drug content. From the studied RSM design, it was observed that small changes in the independent variables (citric acid and effersoda) correlate with shifts in the dependent variables, i.e., the desired responses. The study reveals that all the independent variables (citric acid and effersoda) and dependent variables (effervescent time, hardness, and friability) have a good correlation as indicated by good linear regression coefficient of 0.9808, 0.9939, and 0.9892 for effervescent time, hardness, and friability respectively. Conclusion Levetiracetam effervescent tablets are satisfactorily prepared by dry granulation (roll compaction) approach. All desired critical quality attributes were found to be satisfactory. The applicability of RSM with desirability function in optimizing the levetiracetam formulation has made it possible to identify the impact of various independent variables and explore their effect on required responses.

The primary aim of this review was to improve the solubility and Bioavailability of BCS Class-II drugs because of their low solubility and dissolution rate. Solubility is one of the imp parameter to achieve desired concentration of drug in systemic circulation for pharmacological response to be shown. Hence the class- II drugs require enhancement in solubility and dissolution rate in there formulation development particularly in solid dosage form such as in tablet and capsule. So because of this there are several methods and newer emerging technologies have been developed for increasing the solubility as well as Bioavailability of class –II drugs. In this article review on literature on newer techniques or methods as well as recent research on formulation development of class- II drugs was done.