C ontrol chart is the most successful statistical process control (SPC) tool, originally developed by Walter Shewhart in the early 1920s. A control chart can easily collect, organize and store information, calculate answers and present results in easy to understand graphs. It helps to record data and allows to see when an unusual event, e.g., a very high or low observation compared with "typical" process performance, occurs. Computers accept information typed in manually, read from scanners or manufacturing machines, or imported from other computer databases. The resulting control charts can be examined in greater detail, incorporated into reports, or sent across the internet. A stable process is a basic requirement for process improvement efforts. A computer collecting information in real time can even detect very slight changes in a process, and even warn you in time to prevent process errors before they occur. First, control charts demonstrate how consistently process is performing, and whether you should, or should not, attempt to adjust it. Next, the statistical process control chart compares the process performance to standard pharmaceutical requirements, providing a process capability index as an ongoing, accurate direction for quality improvement. Finally, control charts and its resulting process capability index quickly evaluate the results of quality initiatives designed to improve process consistency. This review focuses on elements of control chart and types of various control charts along with example. Advantages of various control charts are also included.

The objective of this work was to utilize a potential of microemulsion for the improvement in oral bioavailability of raloxifene hydrochloride, a BCS class-II drug with 2% bioavailability. Drug-loaded microemulsion was prepared by water titration method using Capmul MCM C8, Tween 20, and Polyethylene glycol 400 as oil, surfactant, and co-surfactant respectively. The pseudo-ternary phase diagram was constructed between oil and surfactants mixture to obtain appropriate components and their concentration ranges that result in large existence area of microemulsion. D-optimal mixture design was utilized as a statistical tool for optimization of microemulsion considering oil, S, and water as independent variables with percentage transmittance and globule size as dependent variables. The optimized formulation showed 100 ± 0.1% transmittance and 17.85 ± 2.78 nm globule size which was identically equal with the predicted values of dependent variables given by the design expert software. The optimized microemulsion showed pronounced enhancement in release rate compared to plain drug suspension following diffusion controlled release mechanism by the Higuchi model. The formulation showed zeta potential of value -5.88 ± 1.14 mV that imparts good stability to drug loaded microemulsion dispersion. Surface morphology study with transmission electron microscope showed discrete spherical nano sized globules with smooth surface. In-vivo pharmacokinetic study of optimized microemulsion formulation in Wistar rats showed 4.29-fold enhancements in bioavailability. Stability study showed adequate results for various parameters checked up to six months. These results reveal the potential of microemulsion for significant improvement in oral bioavailability of poorly soluble raloxifene hydrochloride.

Serum albumin, often referred to simply as albumin, is a globular protein that in humans is encoded by the ALB gene. Albumin is a multifaceted, highly soluble, stable, nontoxic, non-poisonous, biocompatible and biodegradable plasma protein. Albumin has been widely studied as a protein carrier for drug delivery. Because of its versatile nature, it can also be used for the delivery of the hormones, metals and fatty acids by binding to its specific binding sites. Various studies revealed that albumin can be used to increase the circulating half-life and bioavailability of drug molecules which are smaller than the renal filtration threshold and are rapidly lost from the circulation leading to limiting therapeutic potential. This review article presents advantages, disadvantages, functions, importance, different nanoparticles that can be crowned with an albumin and the special features of albumin as a drug carrier, and how the understanding of these features is currently being employed to optimize the circulatory half-life albumin.

Sailor et al.: Formulation of solid lipid nanoparticle of berberineBerberine is an isoquinoline alkaloid possesses multitude of biological effects. However, quaternary amine cation of berberine causes poor water solubility, resulting in low bioavailability which limits its pharmacological purpose. The aim of this study was to prepare and optimize berberine loaded solid lipid nanoparticle and to evaluate its pharmacokinetic and antihyperlipidemic activity. The solid lipid nanoparticles were prepared by solvent injection method and 3 2 full factorial design was used to study the effect of concentration of polyvinyl alcohol (X 1 ) and amount of lipid (X 2 ) on particle size (Y 1 ) and entrapment efficiency (Y 2 ). The formulation was optimized using desirability function and evaluated for physicochemical, morphological, in vitro drug release and in vivo pharmacokinetic study. In vivo antihyperlipidemic activity of the formulation was also studied using high fat diet induced hyperlipidemia model. The formulation optimized by validated experimental design comprise of 1 % w/v polyvinyl alcohol, 279 mg lipid (stearic acid) to achieve particle size of 395 nm with 82.44 % entrapment efficiency. In vitro release study of berberine loaded solid lipid nanoparticle showed an initial burst release followed by slow and continuous release. Berberine loaded solid lipid nanoparticle also showed 4.13 folds improvement in relative bioavailability compared to Berberine suspension. Furthermore, Berberine loaded solid lipid nanoparticle ameliorate the levels of total cholesterol (-41 %), TG (-49 %), lipoprotein cholesterol-C (-80 %) and high-density lipoprotein cholesterol(+119 %) compared to hyperlipidemic control and also found to be better than pure drug. The prepared berberine loaded solid lipid nanoparticle are successful drug delivery system demonstrating its effectiveness in controlling hyperlipidemia due to the improved bioavailability of berberine.

No abstract