Sowmya
Publications by Sowmya
10 publications found • Active 2012-2025
2025
1 publicationDifferent types, specific packaging and labeling regulatory requirements as per CDSCO in India in comparison with Sweden
This project aims to analyze and compare the regulatory requirements related to packaging and labeling of pharmaceutical products in India and Sweden. In India, these regulations are governed by the Central Drugs Standard Control Organization (CDSCO), whereas in Sweden, they fall under the jurisdiction of the Medical Products Agency (MPA), in line with the European Medicines Agency (EMA) directives. The study categorizes the types of pharmaceutical products-such as prescription drugs, over-the-counter (OTC) medicines, biological and medical devices-and examines the specific packaging and labeling requirements for each category. It investigates critical elements such as Language requirements, font size, barcoding, serialization, tamper-evidence features, and safety warnings, highlighting the underlying rationale rooted in patient safety and traceability. Through comparative analysis, the project identifies key differences and similarities between Indian and Swedish regulations. While CDSCO emphasizes local language labeling and rigid compliance with the Drugs and Cosmetics Rules, Sweden follows harmonized European Union (EU) standards with multilingual packaging requirements and Centralized Pharmacovigilance practices. This comparative study provides insights for pharmaceutical companies looking to market their products in both regions, guiding them to navigate regulatory expectations efficiently. The project also highlights potential challenges and opportunities in harmonizing global regulatory practices.
2016
4 publicationsGastro Protective and anti oxidant activity of Cow urine betel vine extract in ethanol induced Peptic ulcer in Rats
The present study was designed to investigate the antioxidant and gastro-protective potential of Cow urine betel vine extract. Antioxidant and gastro-protective activity was evaluated by using ethanol induced ulcer model; the animals were fed with Cow urine betel vine extract at the dose of 250 and 500mg/kg b.w orally for a period of 14 days. The pretreated extract reduced the gastric ulcers in a dose dependent manner which was determined by measuring the ulcer index and with marked attenuation in the levels of oxidative stress enzymes like SOD, LPO and CAT. Also Cow urine betel vine increased the gastric mucous content in the selected ulcer model.
Evaluation of Cow urine Piper betel extract for antiulcer activity in rats
The antiulcer effect of cow urine extract of Piper betel (family Piperaceae) was evaluated in pyloric ligation induced ulceration model in Wistar rats. The antiulcer activity was evaluated by measuring ulcer index and percentage of ulcer healing. The extract (500mg/kg b.w) showed significant antiulcer activity as evidenced from the data obtained. Histopathological findings also confirm the antiulcer activity of Cow urine Piper betel extract.
Assessment of Nutritional Status of the Government Primary School Children In Slum Area Of Bengaluru, Karnataka
Malnutrition is defined to be the condition resulting from relative or absolute deficiency of one or more essential nutrients. The school age period is nutritionally the prime time to build up the body stores of nutrients in preparation for rapid growth in adolescents. The nutritional state is therefore critical to the development and wellbeing of the nation. The physical growth of the child is thus reflected by different Anthropometric measurements especially height and weight. This study was done to evaluate the level of malnutrition in government (govt.) higher primary school in Bengaluru. Cross sectional descriptive survey was done using a structured questionnaire, the dependent variables for this study were the anthropometric measurable like height for age and independent variables for the study were occupation of parents, family income, maternal education, gender and type of residence (kacha or pucca). A total of 404 children were included from the govt. primary school in the study. It was seen that maximum children belongs to the 13+ age group most of them being boys. Their family monthly income being in the range of Rs.5000 to 6000. Most of their family members are daily laborer’s and housewives by profession. Therefore it can be concluded that the Mother’s Education is directly proportional to the child health. Hence development in fields on family employment, mother’s education will result in improved child health.
Characterization Of Some Birds Egg And Their Cholestrol Estimation
A Study was conducted on varieties of birds eggs there by extracting yolk and albumin. The eggs of java, quail, hen and love bird were chosen for the study and they were procured from commercial farms, bird markets and breeding places. The physical characteristics such as weight, shape, size and colour of the egg were analyzed. The yolk and their albumin were separated and incubated at 500c for a period of 48 hours and their moisture loss was calculated. Similarly, the total cholesterol estimated found high in the hens egg followed by love birds, were least in the quail and java egg. Thus a conclusion was drawn that eggs of different birds are almost same colour but different in size, shape and possess different ratio of yolk and albumin.
2015
3 publicationsAssessment of Health Related Quality of Life in Stroke (Cerebrovascular Accidents) Patients
To assess the influence pharmacist provided patient education on Health Related Quality of life in patients with cerebro vascular disease. This was a prospective observational and interventional study conducted in neurology department at JSS hospital, Mysore. Morisky medication Adherence Scale (MAS), Validated Stroke Specific Quality of Life Questionnaire (SSQoL), was applied to assess the medication adherence behavior and HRQoL in the enrolled patients. At the end of the study period, 78 patients completed all the study follow-ups and 2 patients were considered as drop outs because of the missed follow-ups. The male population (75%) was three folds predominant than the female population (25%) in the study. Hypertension was observed as the major risk factor for stroke in the study patients. At the end of the study, a statistically significant improvement (P
Preparation and Evaluation of Herbal Peel Off Face Mask
Skin is the protective layer of the body exposed to environmental pollution hence, it is essential to protect the skin .The skin on face can be protected by applying various cosmetics intended specially for facial application. It can be a cream, lotion, face mask or peel off mask etc. Peel off mask can be used as the remedy to treat facial skin related problems such as wrinkles, ageing, acne and it can also be used to close the pores. The open pores can cause deposition of dust and result in white heads. Peel off mask can be used for cleansing and moisturizing the skin. Most of the face peel off mask is prepared by polymers which can form thin layer on face. Peel off mask is available in gel form and as dry form. Dead skin cells can be removed by applying peel off mask. Mask can remain on the face for 5-30 minutes, the duration can be varied depending on the ingredients used. Some peel off mask required whole night for better result. It can be prepared with synthetic and herbal ingredients. In this work, the peel off mask was prepared with herbal ingredients such as apple, apricot, orange peel, cucumber, beetroot and other ingredients like polyvinyl alcohol, propylene glycol, polyethylene glycol 400, methyl paraben, lactic acid and water. The preparation was evaluated for its physical characteristics and it was found to have the entire desired characteristics of a peel off mask.
Formulation and Evaluation of the Tramadol HCl Oral Disintegrating Film by Using The Co-processed Superdisntegrants
Oral fast disintegrating films (OFDF) is an emerging technology brings out “formulations taken without water” with quick onset of action and improved patient compliance. The present aim of study is to enhance the dissolution rate of the dosage form by using the different superdisintegrants and co-processed superdisintegrants. The films were prepared by solvent casting method using hydrophilic polymers that rapidly dissolves on the tongue or buccal cavity, delivering the drug to the systemic circulation. The polymer was used HPMC E15, PEG 6000 as plasticizer, citric acid as the saliva stimulating agent, sucrose as the sweetening agents and sodium starch glycolate, crosscarmelose sodium and crospovidone as the superdisintegrants and tween 80 as surfactant . The FTIR reports suggest that drug and excipients were compatible. These oral disintegrating films were evaluated for various evaluation parameters. The in-vitro dissolution studies were conducted as per USP II with sinker. There were three ODFs prepared by using different types of the superdisintegrants, two were prepared by using the co-processed superdisintegrants and one was without any superdisintegrants. Among all formulation, the F6 shown the better in-vitro drug release profile which was prepared by using co-procesed superdisintegrants. It can be concluded that the co-processed superdisintegrants enhances the dissolution rate by comparing with other formulation.
2013
1 publicationVirosomal Drug Delivery System: A Novel Vaccination Technology
Virosomal Drug Delivery System is the novel drug delivery system available which has been a great revolutionary technology in drug delivery in recent years. Virosomes are the immunogenic compositions that include methods of eliciting an immune response. Virosomes are spherical, unilammellar phospholipid bilayer vesicle with a mean diameter of range 120-180nm. These represent reconstituted empty influenza virus envelopes, which contain 70% phosphatidylcholine and remaining 30% neuraminidase (NA) and haemagglutinin (HA) glycoproteins. A virosome can include at least one viral surface envelope glycoprotein expressed on the surface of the virosome. The virosome can also optionally include at least one adjuvant molecule expressed on the surface of the virosome. A virosome is a drug or vaccine delivery mechanism incorporating virus derived proteins to allow the virosome to fuse with the target cell. Virosomes cannot replicate but are pure fusion active vesicles. Virosomal drug delivery depends on the methods used to prepare the encapsulated bioactive material their incorporation into the virosomes and followed by the characterization and formulation of the finished preparations. All these features allow us to consider influenza virosomes as a promising model for antigen and molecular delivery, which could be helpful for the development of new vaccines or immunotherapeutic protocols that combine safety with immunogenicity and their applicability in different fields of medical research. This technology can potentially be used to deliver peptides, nucleic acids or genes, and drugs like antibiotics, anticancer agents, and steroids. In this paper reviewed about the challenges in drug delivery, advantages of virosomes in successful delivery of immunogens, formulation, Virosomal Technology and its various approaches.
2012
1 publicationOptimization of innovative floating gastro retentive dosage form and evaluation of their residence time
The present work investigates the formulation and optimization of floating tablets of Domperidone. Formulations were optimized for gas generating agent content, different viscosity grades of HPMC and its concentration. Study revealed that percentage of NaHCO3 and different grades of HPMC had a major influence on release of drug from hydrophilic matrix tablets and floating properties. Eleven trial batches were undertaken in order to optimize and find out the most suitable formulation and evaluated for various parameters like weight variation, hardness, thickness, friability, floating lag time, total floating time, swelling index, dissolution profile and stability study. The formulation F11 containing 20 mg/ tab. HPMC (K100M) was optimized as the best formulation. Optimized formulations were studied for effect of hardness on floating properties and as well as accelerated short term stability study. Hardness of tablets had greater impact on floating lag time which might be due to decreased porosity. Dissolution profiles were subjected to various kinetic drug release equations and found that drug release from hydrophilic matrixes occurred via anomalous transport mechanism (i.e.) follows both diffusion and erosion mechanism. Hence it is evident from this investigation that gas powered matrix tablet could be promising delivery system for Domperidone with sustained release action and improved drug availability. Keywords: Domperidone. Sustained release. Hydroxyl propyl methyl cellulose. Direct compression. Floating lag time.
