ABSTRACT

The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA). Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

Keywords: Process validation, Quality Assurance, Quality, Pharmaceutical industry.

ABSTRACT

Medicinal plants are a major source of raw material for the traditional system like Ayurveda, Siddha & Unani. Even the modern system of medicine has more than 25 percent of drugs in use, which are either plant based or plant derived. Although several tree possess various medicinal properties, it has been ignored by indigenous & modern system of medicine Melia azedarach L. (Family: Meliaceae) is a deciduous tree that is native to north eastern India. It has several common names such as, White cedar, Persian lilac, Tulip cedar and Chinaberry. The plant has been introduced into several countries in Asia, North America and Latin America. In Jordan it has been planted as an ornamental plant for unrecorded number of years. For the Indian natives it has been known for quite long time, that the tree members of family Meliaceae are good source of folk medications. Extracts of fruits, seeds, leaves of M. azedarach have shown many characteristics of medicinal and pesticidal activities against several pathogenic and pest organisms respectively. In medical and veterinary entomological investigations, extracts of M. azedarach showed efficacy against the tick Boophilus micoplus, the malarial vector Anopheles stephensi, the dengue vector, Aedes aegypti and the human lice Pediculus humanus capitis. Insecticidal, acricidal, fungicidal and rodenticidal potentials of extracts made from various parts of the plant have been proven by many workers in several countries .The effect of M. azedarach extracts on the activity of NADPH-cytochrome reductase and the cholinesterase in insects was also investigated. Antiviral, antibacterial and antifungal potentials of the plant extracts have been reported by many investigators, working on human and animal diseases. Among these diseases are skin Cellulitis and herpes simplex. Keywords: Antiviral, Antibacterial, Antifungal.

ABSTRACT

Oral route has been one of the most popular routes of drug delivery due to its ease of administration, patient compliance, least sterility constraints and flexible design of dosage forms. Recently, Mouth-dissolving drug delivery systems have started gaining popularity and acceptance as new drug delivery systems, because they are easy to administer and lead to better patient compliance. Usually, elderly people experience difficulty in swallowing the conventional dosage forms (tablets, capsules, solutions and suspensions) because of tremors of extremities and dysphasia. Mouth -dissolving drug delivery systems may offer a solution for these problems.

Keywords: Mouth Dissolving Tablet, Oral drug delivery system, Method of preparation, Evaluation.

ABSTRACT

Spectrophotometric method for degradation study of Lamivudine was described. The ultra violet spectrum of acidic, basic and oxidative degraded product was found to substantial difference from pure drug. The extent of degradation can be calculated by comparing the decrease in absorbance at selective wavelength. The UV spectrum of Lamivudine showed maximum absorbance at 270nm. The solution in NaOH showed a decrease in absorbance at 270 nm. So the decrease in absorbance at 270nm was used as measure of extent of degradation in NaOH. In case of NaOH degradation also decrease of absorbance is seen due to degradation but in comparison to NaOH degradation is lesser. In the basic degradation study it was found that Lamivudine is more sensitive to alkaline hydrolysis.

Keywords: Lamivudine, UV spectrophotometry, Degradation.

ABSTRACT

A new simple, precise, accurate and selective RP-HPLC method has been developed and validated for Cefuroxime axetil in oral dosage form. The method was carried out on a Waters symmetry, C8 (150mmX4.6mmX5μ i.d) column with a mobile phase consisting of milli Q water, methanol and glacial acetic acid (49:50:01) and flow rate of 1.5 mL min-1. Detection was carried out at 278 nm. The retention time for Cefuroxime axetil was found to be 6.413 min. The Cefuroxime axetil % recovery was within the range between 92.5- 102.8%. The percentage RSD for precision of the method was found to be not more than 15% and correlation coefficient was 0.98.The method was validated as per ICH guidelines. The developed method was validated for precision, accuracy, sensitivity and robustness. The developed method can be used for routine analysis of titled drug in formulation.

Keywords: Cefuroxime axetil oral suspension, RP-HPLC, C8-column, Related impurities, Method development and Validation.

ABSTRACT

Pharmaceutical and biotech companies are moving from centralized organizations to a virtual network of CROs, academic partners, internal labs, and government agencies. A ―virtual‖ pharmaceutical company is able to access data from its multiple academic partners, CROs, and CMOs from a single hosted data management platform, with each supplier having a secure area for its project data but no view of the others. This approach is almost identical to the current model but with external partners, not internal groups. In the past, collaborations were conducted with document- and Excel®-based exchanges for findings. Document based collaboration misses the context of an experiment that is so crucial to scientific understanding and translation of that data into knowledge. As a result, it is vital that scientific partnerships, both today and in the future, be data centric, context rich, and provenance aware, enabling all relevant data and information about the data to be captured. Technology considerations have been developed such as Hosting and Cloud, Software Infrastructure Management, Security and Audit, Domain Flexibility, Data Capture and Signing, Data Quality, Data Analysis, Dashboards. By capturing this information by default, organizations reduce the risk of losing the value of the collaborative data they have invested so much in generating. Keywords: Flexibility, Data Capture and Signing, Data Quality, Data Analysis, Dashboards.

ABSTRACT

                In this study, the bioactive compounds of soybean have been evaluated using GC-MS. Soybean was extracted with 99% ethanol. Extracted sample was injected, the bioactive compounds are screened. The results revealed the presence of fifteen compounds of which 9, 12, 15-octadecatrienoic acid (z,z,z) (80.20) ,Octadecanoic acid (8.72) and n-hexadecanoic acid (7.14) were the phytocomponents with high peak areas.

Keywords: Bioactive, Compounds, GC-MS, soybean, Phytocomponents.

ABSTRACT

The study was conducted to analyze the phytoconstituents of Plectranthus argentatus plant. The plant sample was extracted using methanol and water in the ratio 9:1. The phytoconstituents study was done using standard procedures [18, 19, and 20]. From the study Plectranthus argentatus was found to contain tannins. saponins, flavonoids, cardiac glycosides, phenols, alkaloids and steroidal rings, but terpenoids, steroids and steroidal nucleus were found to be absent in the plant extract.

Keywords: Plectranthus argentatus, Phytoconstituents, Medicinal herbs, Shrubs.

ABSTRACT

                A simple, precise, rapid, reproducible, accurate and stability indicating reverse phase HPLC method has been developed for the determination of new antipsychotic agent Rasagiline in bulk and in pharmaceutical formulation. An enable develosil ODS mg-5, C₁₈, 150x4.6mm, I.D- 5µm particle size column was used with variable wavelength UV detector. The mobile phase consisting of pH 7.0 Buffer and Acetonitrile in the ratio of 60:40V/V was used. The flow rate was 1ml/min and the effluent was monitored at 210nm. The retention time of the drug was 4.306 minutes. The method was linear over the concentration range of 0.5-150µg/ml. the method precision for the determination of assay was below 2% RSD. The percentage recovery of Rasagiline was 98.2 – 102.1%. The validation of method was carried out utilizing ICH guidelines.

Keywords: Rasagiline, RP- HPLC, Development, Validation, Rasagiline tablets.