There is considerable interest in the skin as a site of drug application for both local and systemic effect. However, the skin, in particular the stratum corneum, possesses a formidable barrier to drug penetration thereby limiting topical and transdermal bioavailability. Skin penetration enhancement techniques have been developed to improve bioavailability and to increase the range of drugs for which topical and transdermal delivery is a viable option. The permeation of drug through skin can be enhanced by both chemical penetration enhancement and physical methods. In this review, we have discussed the physical and chemical penetration enhancement technology for transdermal drug delivery as well as the probable mechanisms of action.

Control 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 parenteral administration route is the most effective and common form of delivery for active drug substances with poor bioavailability and the drugs with a narrow therapeutic index. Drug delivery technology that can reduce the total number of injection throughout the drug therapy period will be truly advantageous not only in terms of compliance, but also to improve the quality of the therapy. Such reduction in frequency of drug dosing is achieved by the use of specific formulation technologies that guarantee the release of the active drug substance in a slow and predictable manner. The development of new injectable drug delivery system has received considerable attention over the past few years. A number of technological advances have been made in the area of parenteral drug delivery leading to the development of sophisticated systems that allow drug targeting and the sustained or controlled release of parenteral medicines.

Novel poly (vinyl caprolactam-co-vinyl acetate) microspheres were crosslinked with N', N' methylene bisacrylamide (NNMBA) prepared by free radical emulsion polymerization. This was done by using vinyl caprolactam, vinyl acetate, and NNMBA with varying amounts. 5-Fluorouracil (5-FU) is an anticancer drug which was mixed into these microspheres during in situ polymerization. These microspheres were characterized by using differential scanning calorimetry (DSC), X-ray diffraction (XRD), and scanning electron microscopy (SEM) techniques. XRD and DSC results indicated that there was uniform distribution of 5-FU drug particles in microspheres, and SEM pictures suggest that the microspheres are in spherical shape. Both encapsulation efficiency and release patterns are found to be dependent on the amount of crosslinking agent and amount of drug loaded. From the results of drug release kinetic studies, an anomalous and nonFickian behavior was observed in the present studies. Furthermore, in vitro release studies indicated the release of 5-FU up to 10 hours.

The main objective of this study was to develop paclitaxel loaded poly (caprolactone) injectable microspheres prepared by solvent evaporation method. Mircoparticles were characterized in terms of particle size and size distribution, surface morphology, drug physical state, and crystalline nature by using master size analyzer, scanning electron microscope, differential scanning calorimetry, and X-ray diffraction. Paclitaxel loading over different concentrations was analyzed by high-performance liquid chromatography. In vitro drug release studies were performed in phosphate buffer saline. Best formulation was selected for in vitro cytotoxic studies by using MCF-7 breast cancer cell lines.

Glimepiride (GMP) is poorly water soluble drug, so solubility is the main constraint for oral its bioavailability. An attempt has been made to increase the solubility of this model drug by formulating solid dispersion (SD) using Poloxamer 188 (PXM 188) as polymer and then formulating SDs tablets of the best formulation of SDs. Tablet formulations were prepared by direct compression technique using superdisintegrant croscarmellose sodium in different concentrations. SDs were evaluated for XRD, SEM, in vitro dissolution profiles, and dissolution efficiency, and developed tablet formulations were evaluated for various pharmaceutical characteristics viz. hardness, % friability, weight variation, drug content, disintegration time, in vitro dissolution profiles, and dissolution efficiency. Among different formulations of SDs, SD containing drug is to polymer ratio 1 : 4 gives best dissolution profile and dissolution efficiency and among tablet formulations, formulations containing 5% croscarmellose sodium gives best disintegration and dissolution profiles compared with other formulations. Results showed that poloxamer is a promising polymer for enhancing the solubility of GMP.

During the past two decades, there has been a steady increase in both the number of antiretroviral medications and the number of possible regimens available to manage human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS). But still, regimen fails due to some reasons such as toxicity, adverse effects, and consequent difficulties with patient adherence. Stavudine is the Food and Drug Administration approved drug for clinical use for the treatment of HIV infection, AIDS, and AIDS related conditions, either alone or in combination with other antiviral agents. The side effects of Stavudine are dose dependent and a reduction of the total administered dose reduces the severity of the toxicity. To reduce the frequency of administration and to improve patient compliance, a once daily sustained release formulation of Stavudine is desirable. Hence, in the present work, an attempt has been made to develop once daily sustained release matrix tablets of Stavudine using putative hydrophilic matrix materials such as hydroxyl propyl methyl cellulose (HPMC) K4M and Carbopol 974P. The prepared extended release tablets were then evaluated for various physical tests like diameter, thickness, weight variation, hardness, friability, and drug content uniformity. The results of all these tests were found to be satisfactory. Formulation F9 extended the drug release till the end of 24 hours and showed higher r values for zero order plot, indicating that drug release followed zero order kinetics. This finding reveals that above a particular concentration, HPMC K4M and Carbopol 974P are capable of providing almost zero order drug release.

Nanocapsules are submicroscopic colloidal drug delivery system and are composed of an oily or an aqueous core surrounded by a thin polymeric membrane. Nanocapsules have recently generated lot of interest in the area of controlled release with availability of biocompatible and biodegradable polymers. Nanocapsules of diltiazem were prepared with an objective of achieving controlled release of the drug in order to reduce the frequency of administration of drug, to obtain more uniform plasma concentration, and to improve patient compliance. Diltiazem was chosen as the model drug, as it is widely used in the treatment of chronic conditions such as hypertension and angina which require prolonged therapy. Nanocapsules were prepared by the interfacial deposition technique by taking different concentrations of polymers and phospholipid mixture. Five best formulations were selected based on the encapsulation efficiency. The morphology of nanocapsules was assessed by scanning electron microscope and they were found to be smooth, spherical, and discrete. The particles followed normal size distribution with particle size in the range of 20 to 380 nm. In vitro release studies indicated prolonged release for all polymers for 48 hours, with polycaprolactone as the best polymer releasing about 95 to 98%. The formulations were stable at 4°C but unstable at 25°C, and hence recommended for storage in refrigeration. Thus, it can be concluded that nanocapsules are a useful technology for controlled release of diltiazem.

In the present investigation, newly developed mixed hydrotropic solid dispersion (HSD) technology precludes the use of organic solvent and also decreases the individual concentration of hydrotropic agents, simultaneously decreasing their toxic potential. 'Mixed-hydrotropic solubilization' technique is the phenomenon to increase the solubility of poorly water-soluble drugs in the aqueous solution containing blends of hydrotropic agents, which may give synergistic enhancement effect on solubility of poorly water-soluble drugs and to reduce concentrations of each individual hydrotropic agent to minimize their toxic effects due to high concentration of hydrotropic agents. Maheshwari has made HSD of paracetamol using urea. In the present study, the aqueous solution of hydrotropic blend (20% urea and 10% sodium citrate) has been found to increase aqueous solubility of poorly water-soluble drug, aceclofenac. This mixedhydrotropic blend was used to prepare solid dispersion of aceclofenac. The prepared solid dispersions have been characterized by IR and XRD studies. They have been studied for dissolution rate enhancement effect. The prepared solid dispersions were found very stable (chemically).

The aim of the present study was to mask the extremely bitter taste of Tramadol HCL, an opioid analgesic, and to formulate a tablet which can rapidly disintegrate in saliva (rapidly disintegrating tablet). The crucial aspect in the formulation of mouth-dissolving tablets is to mask the bitter taste and to minimize the disintegration time. Taste masking was done using sweetening agent and D-mannitol and taste-masked pellets were prepared by extrusion spheronization technique. Prepared pellets were tested for drug content, taste evaluation in oral cavity and molecular property. Pellet shows significant taste masking, confirmed by in vitro taste evaluation; therefore, it was selected for further study. Pellets were evaluated for density, angle of repose, Carr's index, Hausner's ratio and sphericity while tablets were evaluated for disintegration and in vitro dissolution. A 3 ² full factorial design and statistical models were applied to optimize the effect of two factors, i.e. superdisintegrant sodium starch glycolate and taste-masking agent (D-mannitol). In this study, response surface methodology was used for designing of the experiment, generation of mathematical models and optimization study. Taste evaluation of pellets in human volunteers revealed considerable taste masking with a degree of bitterness below threshold value (2.0) within 10 s, whereas Tramadol HCl was rated intensely bitter with a score of +4 for 10 s. The size of the pellets varied from 0.895 to 1.423 mm for different batch and found to be a spherical. Disintegration time of different formulations varied from 30 to 60 s. It was observed that the responses, i.e. disintegration time and sphericity were affected by both the factors. The statistical models were validated and can be successfully used to prepare optimized taste-masked mouth-dissolving tablets of Tramadol HCl with adequate disintegration and shape.