Background: Tolterodine is selective for muscarinic receptors of the bladder and is used in the management of urinary frequency, urinary urgency, and urinary incontinence.

Aim: Development of a simple and sensitive bioanalytical method for the determination of tolterodine to investigate their pharmacokinetic parameters in human plasma and its clinical applications, including bioequivalence studies.

Methods: Extracted tolterodine was chromatographed with a mobile phase of ammonium acetate: acetonitrile (20:80 v/v) at flow rate 0.6ml/min, ESI positive mode and m/z 326.1à147.1, 260à183 for tolterodine and the internal standard, respectively. The bioequivalence study was conducted on 24 volunteers, and the pharmacokinetic parameters AUC0-t, AUC0-inf, Cmax, and Tmax were detected for the assessment of the bioequivalence decision of the two products.

Results: The developed bioanalysis technique showed that the average recovery of tolterodine from human plasma was 107.135%, the lower limit of quantitation was 0.01ng/ml, and the correlation coefficient (r2) was 0.9998. The statistical analysis for the pharmacokinetic parameters using the ANOVA test showed a non-significant difference between both drug products included in the study.

Conclusion: The developed LC/MS/MS method is simple, sensitive, and valid for quantification of tolterodine in plasma and is adequate for its clinical pharmacokinetic studies. Moreover, the generic product was found to be bioequivalent to the reference, and both products can be considered interchangeable in medical practice.

There are many pharmaceutical drug products available in the market in different dosage formsi.e., Tablets, Capsules, Suspensions, Solutions, Injections. Inhalations etc. Each and individual dosage form has its own property of Pharmacological and Pharmacokinetic action on the human body. The primary effect of each dosage form depends on the most important property of the drug product, and it is called Bioavailability. Bioavailability of drugs, in other words, is the amount of drug substance available at the target site to show its respective pharmacological action. Therefore, it is a very important deciding factor of a drug product that individual dosage form contains 100% of the drug substance. There are many quantification tests readily available in different sources like USP, E.Ph, JP, etc. Among different quantification tests, Uniformity of dosage units is one, which will be performed by the quality control department of the manufacturer to assure that the individual dosage form of the batch contains the labeled amount claimed before marketing.

Background: Granisetron is an antiemetic drug that is highly selective to the 5-HT3 receptor, and used in the management of chemotherapy-induced nausea and vomiting, and included in the supportive care plan.

Aim: This work aimed to develop a sensitive, precise, accurate, and specific analytical method for quantitative estimation of granisetron in pharmaceutical products to use it as a quality control tool for testing granisetron products pre-market and post-market distribution to ensure the presence of labeled drug amount in the dosage form.

Methods: Determination of granisetron in commercial pharmaceutical formulations, which are dispensed in hospitals and community pharmacies and administered by patients, by developing an in-house High-Performance Liquid Chromatographic (HPLC) method to add for literature methods a validated selective and sensitive method.

Results: The method is sensitive, specific, selective and linear R2>0.999 within concentration range of 0.2 to 3 μg/ml for dissolution medium USP (pH6.5), and 0.1 to 1.6 μg/ml for dissolution medium pH1.2, 4.5, and 6.8. Moreover, the results were accurate within the range of 98 - 102% and the precision CV% was less than 2%. The assayed tablet’s mean recovery was98.398%. Also, the dissolution results were fulfilling the required limit of 75% percent dissolution within 30 minutes.

Conclusion: The in-house developed analytical method is sensitive and fully validated for use in the quantification of granisetron in pharmaceutical products.

Trials were carried out to deposit a film of Titanium dioxide (TiO2) by Atomic Layer Deposition (ALD) using Titanium Isopropox-ide (TTIP) and H2O as precursors. Due to insufficient partial pressure, no coating was achieved. To increase the partial pressure, a bubbler was fabricated. TTIP was carefully filled in the bubbler, and deposition of TiO2 was obtained by a trial recipe. The number of ALD cycles was varied to obtain films of different thicknesses. The coatings were characterized using Ellipsometry, UV-Vis-NIR Spectrometer, and SEM-EDX.

Training The FDA’s 1997 regulation 21 CFR Part 11 and associate 2003 guidance never intended for life science companies to generate 1,200-page computer system validation (CSV) protocols and reports – and they’re tired of reviewing them.

The demand for highly sensitive and selective optical sensors without the need for complex instrumentation and processing has driven the development of novel nanomaterials for optical sensing applications. Nanoparticles have the potential to be used for biosensing in a diversity of fields and could be further developed into multifunctional sensors able to offer sensitive, specific, rapid, and cost-effective solutions for modern biological research and clinical practice. By utilizing the unique properties of a variety of nanoparticles for biosensing functions, effective biosensors have been developed and applied. In order to increase sensitivities and to lower detection limits down to even individual molecules, nanomaterials are promising candidates due to the possibility to immobilize an enhanced quantity of bioreceptor units at reduced volumes and even to act itself as transduction element. Among such nanomaterials, gold nanoparticles, semiconductor quantum dots, polymer nanoparticles, carbon nanotubes, Nano diamonds, and graphene are intensively studied[1,2]. As an attractive alternative to conventional dyes, fluorescent nanoparticles have greatly increased the sensitivity in a variety of biosensor formats[3].