The aim of present work is to determine and analyse the kinetics of drug release from the matrix tablet by employing various mathematical models. A study was done with Carbidopa and Levodopa ER tablets, 50 mg/200 mg by employing wet granulation technique using Hydroxypropyl methylcellulose and Hydroxypropyl cellulose as matrix forming polymer. The in-vitro drug release profile was carried out in 0.1 N HCl (900 mL) using USP dissolution apparatus II (Paddle) at 50 rpm at an extended time period of 0.5, 0.75, 1, 1.5, 2, 2.5, 3 and 4 hours. The drug release data was obtained, quantitatively correlated and interpreted with various mathematical models viz. Zero order model, first order model, Higuchi model, Hixson-Crowell model and Korsmeyer-Peppas model and evaluated to understand the kinetics of drug release. The criterion for the most suitable model was based on the high degree of coefficient of correlation of drug release profile of Carbidopa Levodopa ER Tablet. Hence, finally concluded as the drug release pattern of Carbidopa Levodopa ER Tablets, 50 mg/200 mg was best fitted with Higuchi square root model and follows Higuchi drug release kinetics which is diffusion controlled.

The aim of the present study was to develop and characterize an oral sustain release drug delivery system for commonly prescribed antipsychotic Quetiapine fumarate. Hydrophilic matrix based tablets using different concentrations of hydroxypropyl methylcellulose (HPMC) viz. K4M CR was developed using dry granulation technique. The prepared tablets were of 400 mg dose and were designed for once-daily administration. The formulations prepared were evaluated for the release of Quetiapine fumarate over a period of 24 hrs. Using USP type I dissolution test apparatus. The prepared tablets were evaluated for physical properties. The in-vitro drug release studies revealed that the tablets containing 12% of HPMC K4M CR of the total tablet weight showed satisfactory results and was able to control the release over 20 hrs. The in-vitro release data of prepared formulations followed Korsmeyer-Peppas and Higuchi kinetics strongly. The selected formulation was compared with the marketed product for the drug release pattern and was matched using similarity factor (f2) above 50. The selected formulation was evaluated in comparison to Quetiapine Extended-release tablets formulation manufactured using wet granulation method. In conclusion, the dissolution profiles and the mathematical model fittings indicate that release of Quetiapine fumarate can be effectively controlled by use of hydrophilic matrix systems.

The Tablet manufacturing process is a complex process, influenced by several process variables The aim of this study was to optimize blending; roller compaction and tablets compression processes using design space approach for a model Anti-Hyperlipidemic drug Fluvastatin. During each processes there are several factors which may affect product quality. So the main objective of present work was to identify various parameters and optimize the parameter for formulation of better product which includes Blending time, Roller force, Compression force and machine speed which were recognized as critical process parameters and were evaluated. A scale up batch is taken to evaluate and optimize the parameters. Critical quality attributes like Blend uniformity, granules parameters, flow behavior, tablet appearance, impact on tablet physical parameters and in-vitro drug dissolution release profile is evaluated to optimize the parameters. The data & test results of blend, granules and tablets at various in-process phases were complied with the specified limits and finished product sample analysis results found to be complying within specifications. This study and results obtained assures that the manufacturing process is reproducible, robust and will yield consistent product, which meets specification.

Quetiapine is indicated for the treatment of schizophrenia as well as for the treatment of acute manic episodes associated with bipolar I disorder. The aim of the present study is to evaluate the effect of manufacturing process on critical quality attribute on In-process parameters (Granules). Quetiapine fumarate was selected as a model drug for sustained release drug delivery system manufactured by wet granulation process 1. To identify the effect of compacted Magnesium Oxide Light in the release behavior of model drug. During the study different percentage of Magnesium Oxide light compacted and granulated by using dichloromethane as granulating solvent. Other excipients with different functionality were added in the formulation such as Microcrystalline Cellulose, Lactose monohydrate, Controlled release polymer Carrageenan, Povidone and Magnesium stearate. Initially Magnesium Oxide light was compacted by using vertical type Roller compactor. From the compacted material 40%-50% screened & 50%-60% retained over #60 mesh is optimized ratio, and this ratio must be maintained to get the targeted release of the said drug from the final uncoated Tablet. To find the release profile of the model drug, Citrate Phosphate buffer at pH 6.4-6.6 with volume 1000ml was selected as dissolution media, apparatus used is USP 2 with stationary basket.

A selective and sensitive liquid chromatography–mass spectrometry (AB SCIEX QTRAP 5500) method was developed for quantitative determination of genotoxic impurity, hexyl chloroformate, in drug substance. The method was developed by derivatizing the hexyl chloroformate (HCF) to complex compound hexyl benzylcarbamate (HBC) by reaction with benzylamine. This method provided good sensitivity for quantification of hexyl chloroformate at a concentration of 10 ppm in 10 mg/mL DEM sample solution. The compounds were chromatographed under isocratic condition on poroshell EC-C18 (2.7 μm particle packed in 4.6 x 50 mm column) column with mobile phase of 0.1% v/v ammonium hydroxide in water (pH adjusted to 6 using acetic acid) and acetonitrile in ratio of 1:1 v/v at the flow rate of 1.0 ml/minute with triple quadrupole Q-Trap 5500 mass spectrometer operated in multiple reaction monitoring mode (MRM). To produce transition ion of 236/152 the molecular mass of 236(M+H) was used as molecular ion. Positive mode electro spray ionization (ESI) was employed as the ionization source. The developed method was validated in terms of specificity, limit of detection (LOD), limit of quantification (LOQ), linearity, precision, accuracy, and robustness. The LOD & LOQ were found at 2.1 and 4.2 ppm, respectively.

Objective: The objective of present work describes developing controlled strategy for wet granulation process by identifying critical process parameters and study was done using DoE in support of Quality by Design (QbD).

Lyophilization also known as freeze drying is a process in which water is removed from a product after it was frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes; freezing, primary drying (sublimation), and secondary drying (desorption). Esomeprazole sodium for Injection 20 mg and 40 mg formulation was developed by optimized Lyophilization cycle. The objective of the research work was to compare the lyophilsation process cycle between Lab scale and scale up batches. The collapse temperature (Tc) for the product was identified using Freeze-drying microscope (FDM). During manufacturing the samples were exposed to above said collapse temperature to study the impact on product quality. Lab scale manufacturing was executed in Tofflon Lyophilizer 0.5 and scale-up batches were executed in Tofflon Lyophilizer 13. The Lyophilisation cycle and analytical results for both the batches were compared.

Aims and objectives: The main objective of the present work is to develop acyclovir powder for solution for infusion with clear solution upon half sealing and formation of stable cake after freezing drying programme. During the development, after half sealing stage, a mild turbid color formation in vials was observed followed by crystal formation. This was later investigated due to presence of residual oxygen content in the headspace of the vial and also in freeze drying chamber. Material and method: Aciclovir, sodium hydroxide and cool water for injection was used to prepare solution for injection. Followed by pre-filtration and sterile filtration into colorless vials and semi seal the vials in freeze-drying mode with rubber stoppers. Final freeze-drying programme was performed and cap them with aluminum caps. Results and discussion: Trial 3 showed stable clear solution after few hours. This was due to lower concentration of oxygen in the headspace, which was obtained due to introduction of nitrogen during filling stage. Conclusion: Crystal formation was due to presence of oxygen in the head space, which can be avoided by maintaining oxygen level below 0.5% in headspace volume of vials and also stable formed after changing the freeze drying cycles.