Stability indicating RP-HPLC method for the determination of Tenofovir in pharmaceutical formulation

Stability indicating high performance liquid chromatography (HPLC) method was developed for the assay of Tenofovir in bulk and solid dose formulation. The HPLC separation was achieved on kromasil C18 (100mm × 4.6mm, 5 μm) column using a mobile phase of Methanol: Potassium dihydrogen orthophosphate buffer (30:70,v/v) at a flow rate of 1 ml min-1 and UV detection at 260 nm. Peak elutes at 7.33 appropriate. The method was validated for linearity, repeatability, accuracy, precision, robustness, limit of detection and limit of quantification. The accuracy was between 99.14 - 99.97%. The highest R.S.D. amongst interday and Intraday precision was found 0.808 and 0.473 respectively.The assay was linear over the concentration range of 10-50 μg/ml (R≈0. 999). The method was robust as no significant change in chromatographic parameters. LOD and LOQ was found to be 0.90 and 2.71 respectively. The stress studies were performed per ICH guidelines to confirm its Stress testing was carried out in presence of acid, base, hydrogen peroxide, heat and light to demonstrate specificity of the method as per ICH guidelines. The developed method could separate the potential degradation products from the Tenofovir peak. It was concluded that highest degradation occurs in basic condition. This proposed method was suitable and practical for analysis the content of Tenofovir in pharmaceutical products and could be of benefit for the prediction shelf life of Tenofovir in marketed formulations.

Floating Drug Delivery System an Aid to Enhance Dissolution Profile of Gastric

With the GRDDS, the dose shape remains controllably in the stomach after oral administration, so that the medication may be continually delivered to its absorption receptors in the intestinal tract. The medicine is delivering in a controlled and extended way. Gastro-retentive dose in the stomach area may last for another few hours and substantially lengthen the gastric residence period of the medicines. While the bulk density in the system for the supply of floating medicines (FDDS) exceeds the gastric fluids, it remains for an extended duration in the stomach without altering the rate of decomposition. The medication distributes gradually as the system floats on the stomach juice. As a consequence, stomach residency takes longer and plasma concentrations are well monitored. The therapy of peptic ulcer illness might be beneficial for local activity in the upper portion of the intestine, i.e., a longer stomach residency. In addition, medicines rapidly absorbed in the GI tract will increase bioavailability through delayed stomach release. The regulated gastric retention of solid dose forms can also be accomplished by the simultaneous administration of pharmacological agents, or by sedimentation, flotation processes, muco-adhesion, expansion, changed shape systems, by delaying the stomach emptying. Keywords: Gastro-retentive drug delivery system, Floating drug delivery system, Muco-adhesion, Bioavailability.

First FDA Approved 3D Printed Drug Paved New Path for Increased Precision in Patient Care

The pharmaceutical industry is developed every year with the aim of public health, safety, and financial growth. Keeping public safety in mind, the industry is mostly concentrated on novel plans in the drug development process and plans on how to increase the curing rate of a disorder and building up the accuracy in patient care. The increase in the number of diseases has led to the generic and branded drug competition by which the pressure on the market has increased. The pharmaceutical manufacturers are attempting to find the needs of patients in different ways. The industries were manufacturing the drugs in unique ways which help to increase their productivity and also to increase the patient experience. Due to this, all pharmaceutical manufacturers are trying to manufacture drugs using 3D printing. In 2015, the industries succeeded by manufacturing the drug Spritam using 3D printing and it was the first prescribed drug manufactured by using 3D printing (3DP). 3DP is the process of depositing powder in a layer upon layer that was opposite to subtractive manufacturing and it is perfect for pharmaceuticals because it provides enhanced accuracy in the development and formulation of dosage forms. The 3DP has different advantages to companies and patients like an increase in dissolution rate, absorption, adherence, efficacy, and long life of branded drugs along with the decrease in pill burden. This process leads to a break in the manufacturing method of drugs but helps to overcome several problems and also helps in better patient outcomes in the solid dose markets.

Recent Approaches for Solid Dose Vaccine Delivery

Recent studies on vaccine delivery systems are exploring the possibility of replacing liquid vaccines with solid dose vaccines due to the many advantages that solid dose vaccines can offer. These include the prospect of a needle-free vaccine delivery system leading to better patient compliance, cold chain storage, less-trained vaccinators and fewer chances for needle stick injury hazards. Some studies also indicate that vaccines in a solid dosage form can result in a higher level of immunogenicity compared to the liquid form, thus providing a dose-sparing effect. This review outlines the different approaches in solid vaccine delivery using various routes of administration including, oral, pulmonary, intranasal, buccal, sublingual, and transdermal routes. The various techniques and their current advancements will provide a knowledge base for future work to be carried out in this arena.

Evaluation of Acetylfentanyl Following Suspected Heroin Overdose When Complicated by the Presence of Toxic Fentanyl and Alprazolam Concentrations

A 34-year-old male was reported to be snorting a white powder that was believed to contain heroin. Toxicological analysis revealed free morphine (356 μg/L), fentanyl (34.7 μg/L), alprazolam (64.9 μg/L), and acetylfentanyl (32.9 μg/L) in femoral blood and 6-monoacetylmorphine (6-MAM, <10.0 μg/L) in vitreous fluid. Norfentanyl was only detected in stomach contents (<1.00 μg/total). Heroin, fentanyl, and acetylfentanyl were also detected in solid dose evidence submitted by law enforcement. The fentanyl and alprazolam concentrations might normally be associated with a fatal outcome and are supported with the distribution of fentanyl and alprazolam being consistent with an acute intoxication. In addition, the presence of 6-MAM and a free versus total morphine ratio of 67.9% provide supporting evidence of a rapid death following intranasal (IN) administration. However, the presence of illicit acetylfentanyl complicates toxicologic interpretation due to overlapping recreational and fatal concentrations of this compound reported in the literature as well as a potential for postmortem redistribution (PMR). Reported acetylfentanyl concentrations have also varied when presented with significant fentanyl concentrations and underscore the need to consider a wide range of illicit opioid compounds when investigating drug-related deaths. Based on our comprehensive toxicologic analysis, the results suggest an acute intoxication primarily by IN administration of acetylfentanyl and fentanyl. In addition, we suggest the presence of alprazolam, 6-MAM, and a percentage free morphine is also consistent with rapid death. The cause of death was officially attributed to an acute combined intoxication of acetylfentanyl, fentanyl, alprazolam, and heroin, with the manner of death as accidental.