- F. Shahnooshi Javad
- Shenoy Ujjwala
- Joice Samuel
- Merlin Thaipparambil Silvan
- Sachin Mathew Mathews
- Rajeswari Ramasamy
- Teena Nazeem
- M. Madhusudhan
- Tintu Babu
- A. M. Nancy
- M. Ashwin Krishna
- Chinchumol Baby
- Deborose Soans
- A. N. Kavitha
- S. K. Roopesh
- Sangam Shrestha
- Kavitha Reddy
- M. Anirudh
- B. Patel Trushitkumar
- Riju Pathak
- Rajindar Singh
- Varun Alves
- N. M. Mahesh
- T. S. Chaluvaraj
- Bincy Varghese
- Manasa S. Reddy
- N. Abilash
- D. Shanmugasundaram
- T. K. Kandavel
- T. Ashok Kumar
- N. R. Gayathri Devi
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All
Chandramouli, R.
- Planning and Execution of Diabetes Awareness and Screening Camp in an Educational Institution
Authors
1 Department of Pharmacy Practice, Krupandhi College of Pharmacy, #12/1, Chikkabellandur, Carmelram Post, Bangalore - 560 035, IN
2 Department of Quality Assurance, Krupandhi College of Pharmacy, #12/1, Chikkabellandur, Carmelram Post, Bangalore - 560 035, IN
Source
Journal of Pharmaceutical Research, Vol 12, No 2 (2013), Pagination: 66-71Abstract
Diabetes has emerged as a major healthcare issue in India and is projected that every fifth diabetic person will be an Indian by 2030. In developing countries like India this problem is further compounded by rapid urbanization and associated increase in stress and diabetes. A one day diabetes awareness screening camp was conducted in an educational institute situated in a rural area. A complete participant history was obtained and parameters like blood pressure, random blood sugar (RBS), and body mass index were evaluated Each participant was individually counselled on signs, symptoms, prevention and management of diabetes with appropriate educational material. A higher mean RBS level was noted in smokers, older participants, in known diabetics and in participants with a family history of diabetes. Additionally, a higher average RBS was noted in low family income group and in participants with low educational background. Awareness of symptoms, knowledge of prevention and management of diabetes are important for dealing with this worldwide burden of diabetes. This study was small but successful attempt to spread the awareness and education on diabetes.Keywords
Diabetes, Random Blood Sugar, Screening, Socioeconomic Status.- Pharmaceutical Pricing in India: A Pharmacoeconomic Perspective
Authors
1 Quality Assurance Department, Krupanidhi College of Pharmacy, Bangalore, 560035, KA, IN
Source
Journal of Pharmaceutical Research, Vol 14, No Special Ed (2015), Pagination: 35-35Abstract
No Abstract.- Study on Determinants of Self Medication Practice amongst Consumers in Parts of East Bengaluru
Authors
1 Department of Pharmacy Practice, Krupanidhi College of Pharmacy, Bengaluru, IN
2 Krupanidhi College of Pharmacy, Bengaluru, IN
3 Department of Community Medicine, MVJ Medical College and Research Hospital, Bengaluru, IN
Source
Journal of Pharmaceutical Research, Vol 14, No Special Ed (2015), Pagination: 56-56Abstract
INTRODUCTION: Self medication is the problem that has the potential to harm society due to irrational use of drugs. The nature and extend of practice of self medication depends upon many factors like nature of the disease, educational qualification of the person, non availability of the specialized person, cultural and social influences.AIM: To identify the socio demographic determinants associated with selfmedication practice in the population of selected area.
METHODOLOGY: A community based cross sectional study was conducted in East Bengaluru area over the period of 6 months using pre tested semi structured questionnaire.The subjects were asked to recollect self medication practice for one year recall period.
RESULTS& DISCUSSION: The data on socio demographic characteristics and practice of self medication were collected from 427 study participants. A significant correlation was observed particular age group ( 24 - 30 years)[Prob>F = 0.0056, Prob>|t| = <0.0001]; while a moderate correlation for education[Prob>|t| = <0.0001], occupation [Prob>|t| = <0.0001] and economic status[Prob>|t| = <0.0001] of the survey respondents. And no particular correlation was observed for gender, familial types and the area of domicile of the participants.
The frequency of self medication use ranged from minimum of one time to all the time.Fever (68.67%), pain (54.56%), and cough (42.15%) were the most common illnesses where self-medication is common. Pain killers (68.85%) and antipyretics (50.58%) were the most commonly used self medicating drugs. Telling the symptoms to pharmacist (89.69%) was the commonest method adopted to procure drugs by the users. The major reason for self medication was lack of time to visit doctor (32.31). Only 33.34% of the subjects agree self medication is harmful; but most of them (66.97%) did not advise others to use self-medication drugs.
CONCLUSION: Self medication is more prevalent among the younger population of the respondents, irrespective of their educational backgrounds andeconomic status. A newer approach to connect with andeducating these consumers is essential.
Keywords
Self Medication, Community Pharmacist, OTC Medications.- Assessment of Knowledge Attitude and Practice on Tuberculosis Patients on Dots Therapy
Authors
1 Department of Pharmacy Practice, Krupanidhi College of Pharmacy, Bengaluru, IN
2 Krupanidhi College of Pharmacy, Bengaluru, IN
Source
Journal of Pharmaceutical Research, Vol 14, No Special Ed (2015), Pagination: 64-64Abstract
Introduction: An estimated incidence figure of 2.2 million cases of Tuberculosis (TB) out of a global incidence of 8.6 million cases was found, making India the world's highest Tuberculosis burden country in 2014. Effective treatment of TB requires compliance to a minimum of 6 months treatment with multiple drugs.Patient adherence to the standard anti-TB therapy in developing countries has been estimated to be as low as 40%. Hence, this study assessed the Knowledge, Attitude and Practice (KAP) among patients on DOTs (Direct Observed Treatment,Short-course) therapy across various DOTS centres in Bengaluru, South India.Aim: The aim of this study is to assess KAP of TB patients in DOTs centers
Methodology: A Prospective-Educational Interventional study on 113 patients, receiving DOTS therapy was conducted on DOT's centres in Hoskote region for a period of six months.Patient's level of knowledge attitude and practice were assessed using suitable KAP questionnaire.
Result & Discussion: Out of 113 patients studied, 46.9 % (N=53) were found to have poor KAP, 52.2 %( N=59) were found to have medium KAP and 0.88% (N=1) were found to have high KAP during the baseline interview. Only sixteen percent of the respondent's family had acceptable attitude whereas eighty two percent of the respondents had non-acceptable attitude. From the study it was clear that there is still a need to strengthen the educational activities on TB through mass media; they are excellent venues for information-dissemination and pharmacist assisted care/counseling.
Conclusion: The prospective-educational study revealed that although knowledge regarding curability and duration of treatment were satisfactory, but knowledge about symptoms, mode of transmission, preventive measures, life style modifications were not up to the mark. There is still a great need to educate individuals on priority basis.
Keywords
Tuberculosis, Knowledge, Attitude, Practice.- Assessment of Knowledge Attitude and Practice on DOTs Therapy by Tubercular Patients
Authors
1 Krupanidhi College of Pharmacy, Bangalore-560 035, IN
2 Krupanidhi College of Pharmacy, Chikka Bellandur, Carmelaram post, Varthurhobli, Bangalore-560 035, IN
Source
Journal of Pharmaceutical Research, Vol 15, No 2 (2016), Pagination: 51-55Abstract
PURPOSE OF THE STUDY: India is marked as world's highest Tuberculosis (TB) burden country in the year 2014 with an estimated incidence of 2.2 million cases.Patient adherence to the standard anti-TB therapy in developing countries has been estimated to be as low as 40%. Therefore we found our study is relevant to the situation.
DESIGN AND METHODOLOGY: A prospective- Educational Interventional study was conducted among 113 patients across DOTs centers in and around Bengaluru. Patient's level of knowledge, attitude and practice towards TB were assessed by conducting structured interviews using suitable validated KAP (Knowledge Attitude and Practice) questionnaire.
RESULT:Of the 113 patients, 46.9 % were found to have poor KAP, 52.2 % were found to have medium KAP and 0.88% of patients were found to have high KAP during the baseline interview.
IMPLICATION AND VALUE OF THE STUDY: A more comprehensive approach for patient education, incorporating easier access to drugs and emphasizing on motivating patients to come to the clinic to receive therapy are essential for completion of treatment course among TB patients.
CONCLUSION: Hence this study assessed level of Knowledge, Attitude and Practice (KAP) among patients with tuberculosis and revealed the need for providing more knowledge about tuberculosis and medications among patients.
Keywords
Knowledge Attitude Practice, KAP, Tuberculosis, DOTs.References
- “TB India 2014,RNTCP,Annual status report” URL: www.tbcindia.nic.in/pdfs/TB INDIA 2014. pdf
- Hoa NP, Chuc NT, Thorson A. KAP about tuberculosis and choice of communication channels.Health Policy.2009;90:8–12.
- Mushtaq MU, Majrooh MA, Ahmad W, Rizwan M, Luqman MQ, Aslam MJ, Siddiqui AM, Akram J, Shad MA. KAP regarding tuberculosis. Int J Tuberc Lung Dis.2010;14:303–310.
- Mushtaq MU, Shahid U, Abdullah HM, Saeed A, Omer F, Shad MA, Siddiqui AM, Akram J. Urbanrural inequities in KAP regarding tuberculosis. Int J Equity Health.2011;10:8.
- Storla DG, Yimer S, Bjune GA. A systematic review of delay in the diagnosis and treatment of tuberculosis.BMC Public Health.2008;8:15.
- JurcevSavicevic, Popovic-Grle A, Milovac S, Ivcevic S, Vukasovic I, Viali M, Zivkovic V. Tuberculosis knowledge among patients in outpatient settings. Int J Tuberc Lung Dis. 2008;12:780–785.
- Mesfin MM, Tasew TW, Tareke IG, Mulugeta GW, Richard MJ. KAP on pulmonary tuberculosis and their choice of treatment supervisor. Ethiop J Health Dev.2005;19:21–27.
- Yousif TK, Mahmoud AL, Khayat I. Survey of KAP: enhanced response to TB ACSM. Middle East J Family Med.2009;7:7–13.
- Khan JA, Irfan M, Zaki A, Beg M. Knowledge, at t i tude and misconcept ion regarding tuberculosis in Pakistan patients. JPMA. 2006;56:211.
- Lawn SD, Afful B, Acheampong JW. Pulmonary tuberculosis: diagnostic delay. Int J Tuberc Lung Dis.2006;4:1190–1191.
- Demissie M, Lindtjorn B, Berhane Y. Patient and health service delay in the diagnosis of pulmonary tuberculosis.BMC Public Health.2009;2:23.
- Venketapraveen A, Rampur MV, Patel N, Hinchageri SSS, Lakshmi D.P. Assessment of clinical pharmacist intervention to improve compliance and health care outcomes of tuberculosis pat ients. Der Pharmacia Lettre.2012;4 (3):931-937.
- Boum Y, Atwine D, Orikiriza P, Assimwe J, Page AL et al. Male Gender is independently associated with pulmonary tuberculosis among sputum and non-sputum producers people with presumptive tuberculosis in Southwestern Uganda.BMC Infectious Diseases 2014.10.12
- Anurag B, Yogesh J, Madhuri C et al. Nutritional support during treatment of pulmonary TB recommended.journal.pone.2013:10.24.1371.
- Crampin AC, Kasimba S, Mwaungulu NJ et al. Married to M.tuberculosis: risk of infection and disease in spouses of smear positive tuberculosis patients. Trop Med Int Health. 2011 July ; 16(7):811–818.
- Ali M, Mallik S, Mehra R. Effect of Social factors on Tuberculosis patients.IJRAP 2013.2.3(1).
- Mondal MN, Nazrul HM, Chowdhury MRK,et al., Socio-Demographic factors affecting Knowledge level of Tuberculosis patients in Rajshahi City, Bangladesh. Afr Health Sci.2014 Dec; 14(4): 85565.
- Dheeraj G, Kshaunish D, Balamughesh T, Ashutosh N. Role of Socio-Economic Factors In Tuberculosis Prevalence. Indian Journal of Tuberculosis.2010.01.Vol.57:No.1.
- Reichmann LB, O'Day R.Tuberculosis infection in a large urban population. Am Rev Respir Dis 1978;117:705-712.
- Solliman M A et al., Assessment of Knowledge towards Tuberculosis among general population in North East Libya. Journal of Applied Pharmaceutical Science.2012;02(04):24-30
- Application of Design of Experiments for Optimizing Critical Quality Attributes (CQA) in Routine Pharmaceutical Product Development
Authors
1 Department of Quality Assurance, Krupanidhi College of Pharmacy, Chikkabellandur Village, Carmelaram Post, Varthur Hobli, Bangalore - 560035, IN
2 Department of Pharmaceutics, Krupanidhi College of Pharmacy, Chikkabellandur Village, Carmelaram Post, Varthur Hobli, Bangalore - 560035, IN
Source
Journal of Pharmaceutical Research, Vol 15, No 3 (2016), Pagination: 96-100Abstract
Purpose: QbD is a helpful tool in building quality products and to understand critical process parameters which affects the manufacturing of drug products. It helps to build control strategy which helps to maintain quality throughout its life cycle.
Approaches: The major approach in QbD is through DOE which includes either screening or optimization done by various designs like plackett-Burmann, Box-Behnken design, Fractional Factorial design, Central Composite design, Mixture design etc.
Findings: QbD approach helps in formulating and maintaining quality in the drug product. It helps to identify the critical quality attributes and process parameters which are likely to affect the quality of the drug product through screening design.
Conclusions: Adopting QbD concepts into manufacturing of the drug product has its advantage of reducing development and marketing costs. It also helps in meeting regulatory requirements.
Keywords
QbD, DOE, Process Optimization, QTPP, CQA.References
- Guideline ICH. Pharmaceutical Development Q8 (R1). Current step.2009 Aug;4.
- Kan S, Lu J, Liu J, Wang J, Zhao Y. A quality by design (QbD) case study on enteric-coated pellets: Screening of critical variables and establishment of design space at laboratory scale. Asian J. Pharm. sci. 2014;31;9(5):268-78.
- Basalious EB, El-Sebaie W, El-Gazayerly O. Application of pharmaceutical QbD for enhancement of the solubility and dissolution of a class II BCS drug using polymeric surfactants and crystallization inhibitors: development of controlled-release tablets. AAPS Pharmscitech. 2011;12(3):799-810.
- Lourenço V, Lochmann D, Reich G, Menezes JC, Herdling T, Schewitz J.A quality by design study applied to an industrial pharmaceutical fluid bed granulation. European J. Pharmaceutics and Biopharmaceutics. 2012;81(2):438-47.
- Chowdary KP, Shankar KR, Kumar PS. Recent research on QbD approach in formulation development:A review. Int.J.Chem.Sci.& Tech.2014;4(1):282-92.
- Ranga S, Jaimini M, Sharma SK, Chauhan BS, Kumar A. A review on Design of Experiments (DOE). Int. J. Pharm. Chem.Sci.2014;3(1):216-24.
- Jain S. Quality by design (QBD): a comprehen-sive understanding of implementation and challenges in pharmaceuticals development. Int. J. Pharm. Pharm. Sci.2014; 6:29-35.
- Telford JK.A brief introduction to design of experiments. Johns Hopkins apl technical digest.2007 Sep;27(3):224-32.
- Simpson TW, Peplinski J, Koch PN, Allen JK.On the use of statistics in design and the implications for deterministic computer experiments. Design Theory and Methodo-logy-DTM'97.1997;Sep 14:14-7.
- Garg RK, Singhvi I. Optimization Techniques: An Overview For Formulation Development.Asian J.Pharm. Res.Vol.2015;5(3):217-21.
- Raman NV, Mallu UR, Bapatu HR. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. Journal of Chemistry.2015 Jan 26;2015.
- Bhoop BS. Quality by Design (QbD) for holistic pharma excellence and regulatory compliance. Pharm Times. 2014;46(8):26-33
- Enhancing the Solubility of BCS Class II and IV Drugs by Sedds Approach-A Structured Review
Authors
1 Krupanidhi College of Pharmacy, Chikka Bellandur, Carmelaram Post, Varthur Hobli, Bangalore-560035, IN
Source
Journal of Pharmaceutical Research, Vol 15, No 4 (2016), Pagination: 174-180Abstract
Purpose: The solubility of orally administered hydrophobic drugs ismajor challenge for pharmaceutical formulators as nearly 35-40% of newly launched drugs possess low aqueous solubility which leads to poor dissolution and low bioavailability, resulting in high intra&inter subject variability&lack of dose proportionality.
Approach: Self-Emulsifying Drug Delivery System, (SEDDS) is gaining popularity for improving the solubility of lipophilic drugs. Therefore, various formulation strategies have been investigated to improve the solubility and the rate of dissolution to enhance the oral bioavailability of lipophilic drugs.
Finding: This review mainly discusses about the mechanism of SEDDS, excipient used in SEEDS, dosage forms, evaluation, applications, advantages and drawbacks.
Conclusion: SEDDS form fine emulsions (or micro-emulsions) in gastro-intestinal tract (GIT) with mild agitation provided by gastric mobility. Many parameters like surfactant concentration, oil/surfactant ratio, polarity of the emulsion, droplet size and charge plays a critical role in oral absorption of drug from SEEDS.
Keywords
SEDDS, Hydrophobic Drugs, Micro Emulsion, Lipid Based System.References
- Kumar A, Sharma S, Kamble R. Selfemulsifying drug delivery system (SEDDS): future aspects. Int J Pharm Pharm Sci. 2010; 2 (Suppl 4):713.
- Garrigue JS, Lambert G, Benita S. Selfemulsifying oral lipid-based formulations for improved delivery of lipophilic drugs. Microencapsulation: Methods and Industrial Applications. 2006:429-80.
- Wakerly MG, Pouton CW, Meakin BJ. Evaluation of the self-emulsifying performance of a non-ionic surfactantvegetable oil mixture. J Pharm Pharmacol. 1987;39(6):b70.
- Craig D. The use of self-emulsifying systems as a means of improving drug delivery. Bulletin Technique-Gattefosse. 1993:21-32.
- Shah NH, Carvajal MT, Patel CI, Infeld MH, Malick AW. Self-emulsifying drug delivery systems (SEDDS) with polyglycolyzed glycerides for improving in vitro dissolution and oral absorption of lipophilic drugs. International journal of pharmaceutics. 1994 May 16;106(1):15-23.
- Craig DQ, Lievens HS, Pitt KG, Storey DE. An investigation into the physico-chemical properties of self-emulsifying systems using low frequency dielectric spectroscopy, surface tension measurements and particle size analysis. International journal of pharmaceutics. 1993 Jul 31;96(1-3):147-55.
- Charman SA, Charman WN, Rogge MC, Wilson TD, Dutko FJ, Pouton CW. Selfemulsifying drug delivery systems: formulation and biopharmaceutic evaluation of an investigational lipophilic compound. Pharmaceutical research. 1992 Jan 1;9(1):87-93.
- Constantinides PP. Lipid microemulsions for improving drug dissolution and oral absorption: physical and biopharmaceutical aspects. Pharmaceutical research. 1995 Nov 1;12(11):1561-72.
- Pouton CW. Self-emulsifying drug delivery systems: assessment of the efficiency of emulsification. International Journal of Pharmaceutics. 1985 Dec 31;27(2):335-48.
- Nigade PM, Patil SL, Tiwari SS. Self Emulsifying drug delivery system (SEDDS): A review. International Journal of Pharmacy and Biological Sciences. 2012 Apr;2(2):42-52.
- Kommuru TR, Gurley B, Khan MA, Reddy IK. Self-emulsifying drug delivery systems (SEDDS) of coenzyme Q 10: formulation development and bioavailability assessment. International journal of pharmaceutics. 2001 Jan 16;212(2):233-46.
- Shah NH, Carvajal MT, Patel CI, Infeld MH, Malick AW. Self-emulsifying drug delivery systems (SEDDS) with polyglycolyzed glycerides for improving in vitro dissolution and oral absorption of lipophilic drugs. International journal of pharmaceutics. 1994 May 16;106(1):15-23.
- Pouton CW. Effects of the inclusion of a model drug on the performance of self emulsifying formulations. Journal of pharmacy and Pharmacology. 1985 Dec 1;37(S12).
- Patil P, Patil V, Paradkar A. Formulation of a self-emulsifying system for oral delivery of simvastatin: in vitro and in vivo evaluation. Acta pharmaceutica. 2007 Mar 1;57(1):111-22.
- Karim A, Gokhale R, Cole M, Sherman J, Yeramian P, Bryant M, Franke H. HIV protease inhibitor SC-52151: a novel method of optimizing bioavailability profile.
- Finite Element Analysis of Equal Channel Angular Pressing on Densification and Deformation Behaviour of Al-1100 Processed by Powder Metallurgy Route
Authors
1 School of Mechanical Engineering, SASTRA University, Thanjavur – 613401, Tamil Nadu, IN
Source
Indian Journal of Science and Technology, Vol 8, No 22 (2015), Pagination:Abstract
Background/Objectives: Pressed and sintered Al-1100 powder is subjected to Equal Channel Angular Pressing (ECAP) process to study densification and deformation behaviour under different initial relative density and shear friction conditions. Methods/Statistical Analysis: Commercially pure Aluminium (Al 1100) powder containing 99% Al, 0.05-0.2% Cu, 0.05% Mn, remainder of Si, Fe and Zn is processed through normal powder metallurgy route followed by ECAP process. Finite Element Analysis through simulations are carried out using DEFORM 2D software for different initial relative densities of 0.700, 0.750 and 0.800 under three friction coefficients of 0.05, 0.075 and 0.15. Effective stresses, strains and loads are plotted. Findings: Full densification is achieved near the inner corner of the die channel compared to the outer corner at the end of the process. Uniform densification (relative almost greater than 0.980) is achieved in the middle portion of the specimen. As the friction is increased load required also increases. Formation of dead zone near the inner corner of the die channel reduces as the initial relative density is increased from 0.700 to 0.800. With higher initial relative density, complete densification occurs in the lower friction conditions like close to 0.05 shear friction coefficient. Effective stress is higher in the plane of intersection of the die channels where the actual deformation occurs. With the increase in initial relative density, effective strain also increases along the length of the specimen whose value is higher near the top portion of the die channel as compared to the bottom portion. Application/Improvements: ECAP eliminates residual porosity. Ultra fine grained structures are produced, even finer (better mechanical properties) than that by ECAP of cast products. Best suited for aerospace, defence and biomedical applications.Keywords
Aluminium, Densification, ECAP, Powder Metallurgy, Simulation.- Assessment of Parents’ Knowledge, Attitude and Practice about Child Vaccination in Rural Areas
Authors
1 Department of Pharmacy Practice, Krupanidhi College of Pharmacy, #12/1, Chikkabellandur, Carmelaram Post, Varthur Hobli, Bangalore - 560035, KA, IN
Source
Journal of Pharmaceutical Research, Vol 16, No 3 (2017), Pagination: 229-236Abstract
Background: Vaccines have thrived as one of the most successful health interventions that have diminished occurrence of infectious diseases and improved quality of life in the population. Although the vaccination coverage has been gradually increasing, the average total immunization coverage is far less than the desired outcome. Parental decisions regarding vaccination are very vital for increasing the vaccination rate and parent compliance to the immunization schedule.
Objective: To analyze the extent of parents' Knowledge, Attitude and Practice(KAP) about child vaccination in rural areas such that it can be correlated with the immunization status of their child amongst native participants of Bangalore.
Methodology: A prospective cross-sectional study was carried out on 110 Parents residing in rural areas of Bangalore who had children below 5 years of age. The sociodemographic details of the parents were collected and they were made to fill a KAP Questionnaire. Each question under Knowledge and Attitude was scored to assess their KAP level regarding child vaccination. The immunization status of the child was assessed by counting on the parents' word for it.
Results: A total of 110 parents participated in the study from different rural clusters of Bangalore. Assessment of the extent of Knowledge, attitude and practice about child vaccination showed that a majority of them (72.7 %,) had good knowledge score followed by average (21.8%) and poor (5.4%) whereas 85.4% of the respondents were found to have good attitude towards child vaccination. The immunization status of the child was assessed by counting on the parents' word for it and.68.1% children were completely immunized whereas 7.2 % received incomplete immunization. The immunization status of the remaining 24.5% of the children was uncertain as assessment was not possible due to lack of surety in the parents part regarding the immunization status of their child. Although parental knowledge was not found to be significantly associated with the immunization status of their child, there was a significant association between the attitude of parents towards child vaccination and the immunization status of their child. A very significant correlation was also seen between the parental knowledge and attitude score with p≤0.0001.
Conclusion: The parental Knowledge, Attitude and Practice about child vaccination are important determinants of the immunization status of their child. A combined effort from the members of the healthcare team and social health workers can definitely make the attainment of the targeted immunization coverage rate in the country possible.
Keywords
Immunization, Knowledge, Attitude, Practice, Vaccines.References
- Vaccines [Internet]. South-East Asia Regional Office [cited 8 July 2015]. Available from: http://www.searo.who.int/topics/vaccines/en.
- National Vaccine Policy [Internet] [cited 14 July 2015]. Available from:http://mohfw.nic.in/Write ReadData/l892s/1084811197NATIONAL%20 VACCINE%20POLICY%20BOOK.pdf.
- Introduction [Internet]. UNICEF [cited 8 July 2015]. Available from: http://www.unicef.org/ immunization/index_2819.html
- Summary- Report On Causces Of Death: 2001-03 In India.: Office of the RGI, Pg No.1-7.
- Universal Immunization Program [Internet]. 1st ed. India: Ministry of Health and Family Welfare; 2015 [cited 6 August 2015]. Available from: http://www.mohfw.nic.in/WriteReadData/l892s/5628564789562315.pdf.
- Patra N. Universal Immunization Programme in India: The Determinants of Childhood Immunization. SSRN Electronic Journal.
- Mathew J. Inequity in childhood immunization in India: A systematic review. Indian Pediatr. 2012;49(3):203-223.
- International Institute for Population Sciences (IIPS) and Macro International. 2007. National Family Health Survey (NFHS-3), 2005-06, India: Key Findings. Mumbai, Pageno.9.
- Hamid S, Andrabi SAH, Fazli A, Jabeen R. Immunization of Children in a Rural Area of North Kashmir, India: A KAP Study. Online J Health Allied Scs. 2012;11(1):10.
- K.Ravishankar, M.Vinodkumar, E.Surendra and G.Aasrtiha Williams; Knowledge, attitude and practices of rural mothers with children under five years of age about vaccination: a non experimental study, ISSN: 2230 – 7583. IJAPR /April. 2015/ Vol. 6/Issue.04/ 88 – 93.
- American Society of Health-System Pharmacists. ASHP guidelines on the pharmacist’s role in immunization. Am J Health-Syst Pharm. 2003; 60:1371–7.
- Vashishtha V. Status of immunization and need for intensification of routine immunization in India. Indian Pediatr. 2012;49(5):357-361.
- Micro Planning for Immunization Activities [Internet]. [cited 10 October 2015]. Available from:http://www.undp.org/content/dam/india/docs/NIPI/Resources_CapacityBuildi ngMaterials_ImmunizationModule2.pdf.
- Mahalingam S, Soori A, Ram P, Achappa B, Chowta M, Madi D. Knowledge, attitude and perceptions of mothers with children under five years of age about vaccination in Mangalore, India. Asian Journal of Medical Sciences. 2014;5(4).
- Nath B, Singh JV, Awasthi S, Bhushan V, Kumar V, Singh SK. KAP Study on Immunization of Children in a City of North India – A 30 Cluster Survey. Online J Health Allied Scs. 2008;7(1):2
- Qutaiba B Al-lela O, Bahari M, Al-Qazaz H, Salih M, Jamshed S, Elkalmi R. Are parents' knowledge and practice regarding immunization related to pediatrics’ immunization compliance? A mixed method study. BMC Pediatrics. 2014;14(1):20.
- Kadri AM, Singh A, Jain S, Mahajan RG, Trivedi A. Study on immunization coverage in urban slums of Ahmedabad city. Health and Population: Perspective and issues . 2010; 33 (1): 50-54.
- Bofarraj M. Knowledge, attitude and practices of mothers regarding immunization of infants and preschool children at Al-Beida City, Libya 2008. Egypt J Pediatr Allergy Immunol. 2011;9(1):29-34.
- Mereena MR, A study on knowledge and attitude regarding vaccines among mothers of under five children attending pediatric OPD in a selected Hospital at Mangalore. IOSRJNHS. 2014;3(5):39-46.
- Al-Zaharani J. Knowledge , Attitude and Practice of Parents Towards Childhood Vaccination. MJHS. 2013;1(1):23-32.
- Zelaya- Bonilla JE, Mata- Gamarra JI, Mills-Booth E. Ia perception de la vaccination Par les meres au Honduras-.Carnets de I’enfance 1985;69/72:457470.
- Angadi M. A Study of Knowledge, Attitude and Practices on Immunization of Children in Urban Slums of Bijapur City, Karnataka. JCDR. 2013.
- Hu Y. Knowledge, Attitude and Practice on Immunization among Migrant Mothers: A Questionnaire Development and Field Application. Int J Vaccine Immunizat. 2015;2(1).
- Avinash Kumar B, Unnikrishnan, Rekha T, Prasanna Mithra, Nithin Kumar, Vaman Kulkarni,Ramesh Holla, and Darshan B.B., Awareness and Attitude Regarding Breastfeeding and Immunization Practices Among Primigravida Attending a Tertiary Care Hospital in Southern India; JCDR 2015 Mar, Vol-9(3): LC01-LC05
- Functional Overview of Process Validation of Tablets - A Critical Review
Authors
1 Department of Quality Assurance, Krupanidhi College of Pharmacy, #12/1, Chikkabellandur, Carmelaram Post, Varthur Hobli, Bangalore - 560035, KA, IN
Source
Journal of Pharmaceutical Research, Vol 16, No 3 (2017), Pagination: 268-277Abstract
Purpose: Validation is a main tool in achieving and maintaining the quality and safety of the final product as per cGMP(current Good Manufacturing Practice). The purpose of this present work is to give introduction, general overview and how to plan, develop, execute process validation of pharmaceutical manufacturing process especially tablet manufacturing process.
Approach: When we consider any product, quality is always an imperative pre requisite hence a highest quality levels must be included in the manufacturing of the drug.
Findings: To assure the identity, purity, safety, efficacy and also maintaining the quality of final product process validation is the key element. Three consecutive batches were considered to execute the process validation activity.
Conclusion: Process validation is a major requirement of cGMP's regulation. Process validation is a key element to maintain product quality, safety, identity and efficacy.
References
- Aulton, M. E. "the science of dosage form design, Churchill Livingstone, London." (2002): 322-334.
- European Commission, Qualification and Validation, Annex 15 to the EU guide to GMP. Brussels, 2001,6.
- Committee on specifications for pharmaceutical preparations. Good manufacturing practice for pharmaceutical products. WHO technical report series no. 82. Geneva: world health organization, 1992,p.14-79.
- Herbert A. Lieberman, Leon Lachman, Joseph B. Schwartz, Pharmaceutical Dosage Forms Tablets, second edition, volume 3, Marcel Dekker. Inc, New York, 1990, 417-447.
- Rockville MD. Guideline on General Principles of Process Validation. US Food and Drug Administration., US FDA. 1987.
- Nandhakumar L, Dharmamoorthy G, Rameshkumar S, Chandrasekaran S. An overview of pharmaceutical validation: Quality assurance view point. IJRPC. 2011;1:1003-4.
- Kelley BD. Identification and establishment of operating ranges of critical process variables. Biopharmaceutical Process Validation, Marcel Dekker, New York. 2000 Apr:29-60.
- Dholakia SP, Valiya AP, Thakar TM, Patel JS, Patel MM. Minireview: Process Validation as Essential Tool in Pharmaceutical Industry.
- Sharma V, Seth N. Pharmacy Review & Research
- Paruchuri R, Trivedi S, Pavuluri G. Prasanthi B and Senthil Kumar M. Process Validation of Finasteride Tablets. International journal of pharmaceutical, chemical and biological sciences. 2012;2(1):11-28.
- Ajay S, Seema S. International Journal of Research in Pharmacy and Science. Int. J. Res. Pharm. Sc. 2013:12.
- Jatto E, Okhamafe AO. An Overview of Pharmaceutical Validation and Process Controls in Drug Development. Tropical Journal of Pharmaceutical Research. 2002;1(2):115-22.
- Agalloco JP. Practical consideration in retrospective validation. Pharm tech. 1983 Jun;7(88):90.
- Mayer RJ. Validation of Product and Process, PPMA. InSeminar on Validation of solid Dosage form Processes. Atlanata May–1980.
- Jena S, Arjun G, Kumar DS, Vinod KR, Banji D. Industrial process validation of solid dosage forms-An overview. Int J Pharm Sci Rev Res. 2010 Sep;4(2):145-54.
- Dashora K, Singh D, Saraf S. Validation-the essential quality assurance tool for pharma industries. Cited from www. pharminfo. net. 2005 Sep;3:45-7.
- Chitlange SS, Pawar AS, Pawar HI, Bhujbal SS, Kulkarni A. A review on validation. Cited from http://www. pharmainfo. net/reviews/validation. 2006;4:318-20.
- Nash, R. A., Wachter, A. H., Pharmaceutical Process Validation, Vol.129, An International 3rd Edition, Revised and Expanded, Marcel Dekker, New York, March 2003, 28-29.
- WHO G. Good Practices in Manufacturing of Pharmaceutical Products in WHO Expert Committee on Specifications for Pharmaceutical Preparations. Geneva, April. 1992.
- Tho I, Bauer-Brandl A. Chemometrics (PCA) in pharmaceutics: tablet development, manufacturing and quality assurance. INTECH Open Access Publisher; 2012.
- Wazade MB, Walde SR, Ittadwar AM. An Overview of Pharmaceutical Process Validation And Process Control Variables of Tablets Manufacturing Processes In Industry. International Journal of Pharmaceutical Sciences and Research. 2012 Sep 1;3(9):3007.
- Gupta GD, Garg R, Aggarwal S. Guidelines on General Principles of Validation: Solid. Liquid and Sterile dosage forms. 2008;6(1).
- Nash RA, Wachter AH. Pharmaceutical Process Validation, Vol. 129, An International 3rd Edition, Revised and Expanded, 201-208.
- Biowaivers-An Updated Review
Authors
1 Department of Quality Assurance, Krupanidhi College of Pharmacy, #12/1, Chikkabellandur, Carmelaram Post, Varthur Hobli, Bangalore - 560035, KA, IN
Source
Journal of Pharmaceutical Research, Vol 16, No 3 (2017), Pagination: 278-281Abstract
PURPOSE: A Biowaiver has been regarded as an official approval of the waiver for conducting a bioequivalence study in the context of an application for drug approval process. Bioequivalence is an important parameter in the process of drug development that is needed to be performed when there is a change in the formulation of dosage form.
Approach: The approach of biowaivers is necessary to waive a complete and systemic Bioequalence study, which as a fast track approach to boost the drug development process.
Findings: This review mainly discusses about the criteria for Biowaivers, requirements for a BCS based biowaiver study, conditions to grant the BCS based biowaiver, Applications, limitations, supporting data for Biowaivers.
Conclusion: BCS biowaiver studies in preparing a submission for worldwide filing to satisfy US, European, and emerging market regulators. It is hoped that the availability of BCS Class I and Class III biowaivers in multiple jurisdictions will encourage more sponsors to request waivers of in vivo bioavailability/bioequivalence testing using the BCS approach.
Keywords
Biowaivers, BCS Class, BABE Studies, Drug Development.References
- Kortejarvi H, Urtti A, Yliperttula M.Pharmacokinetic simulation of biowaivercriteria: the effects of gastric emptying, dissolution, absorption and elimination rates. Eur J Pharm Sci. 2007; 30: 155-66.
- Dressman JB, Nair A, Abrahamsson B, Barends DM, Gischolar_main DW, Kopp S, et al. Biowaivers Biowaiver monograph for immediate-release solid oral dosage forms: Acetylsalicylic acid. J Pharm Sci. 2012; 101: 2653-67.
- Midha KK, Rawson MJ, Hubbard JW. The bioequivalence of highly variable drugs and drug products. Int J Clin Pharmacol Ther 2005 Oct; 43(10):485-98.
- Kortejarvi H, Urtti A, Yliperttula M. Pharmacokinetic simulation of biowaiver criteria: the effects of gastric emptying, dissolution, absorption and elimination rates. Eur J Pharm Sci. 2007; 30: 155-66.
- U.S. Department of Health and Human Services. Food and Drug Administration.
- Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Center for Drug Evaluation and Research (CDER) August 2000 (Available at: http://www.fda.gov/cder/ guidance/index.htm ).
- Ku MS. Use of the Biopharmaceutical Classification System in Early Drug Development. The AAPS Journal 2008; 10(1): 208-212Criteria for biowaivers. Accessed at http://www.anapharm. Com/site/upload/site/Generateur/ WilliamsRogers.pdf.
- World Health Organization (WHO) 2006 Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release,solid oral dosage forms Accessed on January 10, 2011 at http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf#page=403.
- World Health Organization (WHO) 2006 Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms Accessed on January 10, 2011 at http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf#page=403.
- Guidance for Industry Waiver of in vivo Bioavailability & bioequivalence Studies for immidate release Solid Oral Dosage Forms Based on a Biopharmaceutical Classification System. Accessed at http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInfor ation/Guidances /ucm070246.pdf.
- Guidance for Industry Waiver of In vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System Accessed at: http://www.fda.gov/ OHRMS/DOCKETS/98fr/3657gd3.pdf.
- Gupta E, Barends DM, Yamashita E, Lentz KA, Harmsze AM, Shah VP, Dressman JB, Lipper RA. Review of global regulations concerning biowaivers for immediate release solid oral dosage forms. Eur J Pharm Sci 2006; 29: 315-24.
- World Health Organization. Prequalification of Medicines Programme Guidance Document. General notes on Biopharmaceutics Classification System (BCS)based biowaiver applications. November 2011.
- World Health Organization. Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series 2006; No. 937.
- European Medicines Agency. Guideline on the Investigation of Bioequivalence, Committee for Medicinal Products for Human Use (CHMP). Doc. Ref.: CPMP/EWP/QWP/1401 / 98 Rev. 1/ Corrected, 2010.
- Yu LX et al. Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions. Pharmaceutical Research 2002; 19(7): 921-925.
- Lindenberg M, Kopp S and Dressman JB. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system. European Journal of Pharmaceutics and Biopharmaceutics 2004; 58(2): 265–278.
- Polli JE. Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond. The AAPS Journal 2008; 10(2): 373-379.
- Yasir M, Asif M, Kumar A, Aggarval A. Biopharmaceutical Classification System: An Account. International Journal of PharmTech Research 2010; 2(3): 16811690.
- World Health Organization (WHO) 2006 Proposal to waive in vivo Bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms Accessed on January 10, 2011 at http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf#page=403.
- World Health Organization, Additional guidance for organizations performing in vivo bioequivalence studies. World Health Organization:Technical ReportSeries, No. 937, Annex 9, Geneva; World Health Organization: 2006.
- Densification and Deformation Behaviour of Sintered P/M AL-C-CU-MG Alloys During Cold Upsetting
Authors
1 School of Mechanical Engineering, Shanmugha Arts, Science, Technology & Research Academy (SASTRA), Deemed University, Thanjavur-613402, Tamil Nadu, IN
Source
Manufacturing Technology Today, Vol 5, No 7 (2006), Pagination: 5-8Abstract
The present investigation is focused on the densification behaviour of sintered aluminium alloys of AI-Cu-C with additions of magnesium powder in varying quantities. The influence of normalizing heat treatment on deformation behaviour has also been investigated. Magnesium powder (-150 μ) has been added in varying percentage to Al-Cu-C alloy phase in order to study the influence of Mg on the deformation, densification and metallurgical structure of the P/M Al alloys mentioned above. Elemental powders of Al, Mg, C &Cu were mixed thoroughly in a pot mill for 8 hrs and the powder blends were compacted In to cylindrical shaped preforms of aspect ratio 0.6, applying a pressure of 125 MPa. in hydraulic press. After sintering at 550 °C for 90 minutes cold upsetting tests were carried out on the preforms. Another set of cold upsetting tests were undertaken after subjecting the sintered preforms to normalizing heat treatment at 500 °C. Density and dimensional measurements were carried out after each step of deformations. Axial upsetting was continued upto the point of appearance of fine surface cracks on the bulged surfaces. The results of the investigations revealed that the normalizing heat treatment notably Influenced the flow stress of the alloys. However It has marginal effects on densifications. Addition of higher percentage of Mg to Al-1% C-1% Cu alloy has also affected the deformation as well as densification behavior. Increasing the Mg content has lead to reduced levels of plastic deformation as well as densification. The combination o f addition of Mg and heat treatment has Influenced the flow stress because adding higher Mg demands higher flow stresses during axial upsetting. Normalizing of the alloys with Mg content enhances the resistance to deformation and densification. Addition of Mg to the alloy AI-C-Cu has reversed the response of the material during cold upsetting. The microstructure of the alloys reveals the presence of numerous rounded and small pores with in the grains and along the grain boundary. It also reveals subtle differences due to normalizing heat treatment.- Cold Deformation Studies on P/M AL-C-CU-FE Alloys
Authors
1 School of Mechanical Engineering, Shanmugha Arts, Science, Technology & Research Academy (SASTRA), Deemed University, Thanjavur-613402, Tamil Nadu, IN
Source
Manufacturing Technology Today, Vol 5, No 5 (2006), Pagination: 11-15Abstract
Aluminium based MMC's with SiC reinforcement are known to find numerous applications in the aerospace and automotive industry In view of high strength to weight ratio and stiffness. Alloys with Cu, Zn, Mg added to Al are also high strength light weight materials widely used in aerospace industry for application such as landing gears, fasteners etc,. In the present investigation atomized iron powder has been added In varying percentages to Al-Cu-C alloy phase in order to study the influence of Fe on deformation, densification and metallurgical structure of sintered Al alloys. Elemental powders of Al, Fe, C & C u were mixed thoroughly In a pot mill for 8 hrs and the powder blends were compacted in to cylindrical shaped performs of aspect ratio 0.6. After sintering at 550°C for 90 minutes cold upsetting test were carried out in the performs. Another set of cold upsetting test were undertaken after subjecting the sintered preforms to normalizing heat treatment at 500°C. Density and dimensional measurements were carried out after each step of deformation level. The results of the investigations revealed that the normalizing heat treatment notably influenced the flow stress of the alloys. However it has only marginal effects on densification. Addition of Fe to AI-1% C-1%Cu alloys in the proportion of 0.1, 0.2, and 0.3 has also affected the deformation as well as densification behavior. Increasing the Fe content has lead to reduced levels of plastic deformation as well as densification. The combined effects of addition of Fe and heat treatment have affected the flow stress. Adding higher Fe contents demands higher flow stress. Normalizing of the alloys with Fe contents enhances the resistance to deformation and densification. The stress-strain behavior in all the cases of the alloys is characterized by linearity. The peak density levels achieved after the forging not exceed 96% of theoretical density. The microstructure of the alloys reveals the presence of numerous rounded and small pores within the grains and along the grain boundary.- Real Time Release Testing-A Review
Authors
1 Department of Quaity Assurance, Krupanidhi College of Pharmacy Bangalore, Karnataka, IN
Source
Journal of Pharmaceutical Research, Vol 16, No 4 (2017), Pagination: 314-318Abstract
QbD is a systemic approach to attain a intended product quality, the tools which assist the QbD principle are design space and Process Analytical Technology(PAT).Now Modern application called Real Time Release Testing has came in to existence which can be accompanied with or without design space and PAT tools. Real time release testing is set of In-process controls that provide greater assurance of product quality than end - product testing under specific conditions. RTRT involves at-line and on-line measurements of critical quality attributes for eg., (tablet weight after compression, moisture measurement during drying, blend uniformity)where they are generated to ensure the product quality in real time. This real time release testing challenge is to perform the right measurement at right time and at the right location. RTRT improves and enhances analytical testing without affecting either product quality or manufacturing cycle.Keywords
Real Time Release Testing, PAT, End-Product Testing.References
- Real Time Release Testing http://www.industry. siemens.com/verticals/global/Documents/pateventslides/4_real-time-release-testing.pdf (2010)
- Parametric Release-European Commission http:// www.emea.eu-int/htms/human/qwp/qwpfinhtm( 2001)
- EMA, “Guideline on real time release testing (formerly Guideline on parametric release)” March 2012.
- FDA, Regulatory Perspective on Real Time Release Testing – American Association of Pharmaceutical Scientists Meeting, (Washington, DC) October 2011
- Angie Drakulich., Real Time Release Testing, Pharmaceutical Technology, 35, 2011, 42–49.
- Real Time Release Testing - PAT seminar
- FDA, Regulatory Perspective on Real Time Release Testing – American Association of Pharmaceutical Scientists Meeting, (Washington, DC) October 2011.
- Dasu. M, Naresh. R. Real Time Release Testing-A New Paradigm For Pharmaceutical Development. International Journal Of Pharmaceutical Sciences Review & Research, Mar/Apr 2013, Vol.19 Issue 2, p80
- Real Time Release Testing for Beginners www.slideshare.net/shettyuc/real-time-releasetestingfor-beginners(2012)
- pharmaceutical “Quality By Design”(QbD):An Introduction,Process Development & Applications http://learnaboutgmp.com/pharmaceuticalqualityby-design-qbd-an-introduction-processdevelopmentand-applications/
- Process Analytical Technology https://en.wikipedia.org/wiki/Process_analytical_technology (2016)
- Strategic Control https://en.wikipedia.org/wiki/ Strategic_control(2017)
- Critical Quality Attributes https://en.wikipedia.org/wiki/Critical_quality_attributes(2017)