QbD enabled Process Variable Study to Develop Sustained Release Chitosan-Alginate Embedded Delivery System for Improved Patient Compliance

Abstract The current investigation entail systematic Quality by Design (QbD)-enabled approach for the development of Sustained released embedded drug delivery systems of L-Arginine employing ionic gelation technique to attain improved patient compliance. Hence, in this QbD enabled systematic approach; quality target product profile (QTTP) was defined and critical quality attributes (CQAs) were identified. Further the risk assessment studies were undertaken through Ishikawa fish bone diagram to locate the critical material attributes (CMAs) and/or critical process parameters (CPPs) for the formulation of beads that may affect CQAs of drug product. A face centered central composite design (CCD) for two factors at three levels each with α =1 was employed for the optimization process to checkout the impact of concentration of sodium alginate and concentration of chitosan as CMAs which wereprior identified from risk assessment study and further evaluated for CQAs viz. bead size, swelling index and percent drug entrapment. The optimum formulation was embarked upon by using mathematical model being developed yielding desired CQAs. Thereby chitosan coated calcium-alginate delivery system was successfully developed by strategically employing QbD approach.In a nutshell, the presentinvestigation reports the successful development of optimized chitosan coated alginate beads employing QbD approach which can serve as a platform for other drugs too.

Study of Pulmonary Manifestations among Dengue Patients in Tertiary Care Hospital of North India

Introduction: Thoracic manifestations such as pleuraleffusion, pneumonia, and haemoptysis have been reportedin dengue infection. Dengue haemorrhagic fever (DHF) canresult in acute respiratory distress syndrome. Dengue shocksyndrome (DSS) is reported to be the third leading cause ofARDs in dengue endemic area. Current research aimed tostudy pulmonary manifestations among dengue hospitalizedpatients.Material and Methods: This study was conducted in 50patients of dengue confirmed by dengue serology. Respiratorymanifestations were recorded and all clinical examinationfindings were recovered. Baseline investigations includingcomplete blood count, liver profile, renal profile, arterial bloodgas analysis, dengue virus IgM and IgG and ns1 antigen, chestx-ray, ultrasound thorax and abdomen ultrasonography weredone.Results: Young age patients and patients with co-morbidityare risky to severe form of dengue fever and have a high riskof death. As regards co-morbidities, chronic chest disease andcardiac disease are mostly vulnerable to Dengue HaemorrhagicFever and Dengue Shock Syndrome. The most presentingrespiratory manifestations were Acute Respiratory DistressSyndrome followed by pneumonitis and pleural effusion.Conclusion: Incidence of pulmonary complications amongcases of Dengue is quite high and therefore can be used asan indicator of serious presentation of dengue in the patients.

Pharmacognostic Studies Of Organically Cultivated Panacea Herb Cynodon Dactylon (l.) Pers.

This research paper knuckles down the organic agripractices of the Cynodon dactylon (L.) Pers.. It is a powerhouse house of multiple macro and micro nutrients including protein, carbohydrates, carotenoids, flavonoids, phenolic compounds and vitamins. Organic cultivation practices enhances these secondary metabolites biosynthesis resulting in therapeutic potential of the crude drug. The field experimental work was conducted from Nov, 2018 up to Mar, 2019 in Department of Medicinal Plants Sciences at Dev Sanskriti Vishwavidyalaya, Haridwar (U.K), India. Cynodon herb belonging to Poaceae family was organically cultivated in our herbal field laboratory (no. 4) by planting slips line to line in experimental blocks. Physical parameters were studied including total Ash (9.9 % w/w), Acid-insoluble Ash (5.8 % w/w), Water-soluble Ash (2.4 % w/w), Alcohol soluble extractive (39.2 % w/w) and Water soluble extractive (39.8 % w/w). Based upon results, it is concluded that secondary metabolites are highly biosynthesized during organic agri practices. Cynodon is credited as panacea herb due to its vital therapeutic benefits in curing multiple acute and chronic diseases or disorders including erysipelas, depigmentation, hysteroepilepsy, Irritable bowel syndrome (IBS) and menstrual irregularities.

Comparative Study of Effects of Dexmedetomidine as Adjuvant to Bupivacaine and Bupivacaine Alone in Epidural Anesthesia.

Background: Epidural anesthesia is one of the most used anesthetic technique for a lower abdominal and lower limb surgeries. Aim: The aim of the present study was to compare dexmedetomidine as an adjuvant with bupivacaine with plain bupivacaine in epidural anesthesia with respect to onset and duration of sensory and motor block, duration of analgesia, hemodynamic changes, adverse effects and sedation. Materials and Methods: A total of 60 patients of either sex with age ranging from 18 to 65 years and belonging to ASA Grades I and II physical status, scheduled for surgery under epidural anesthesia. The patients were divided into two groups with 30 patients each. Group 1 was given 20 ml 0.5% plain bupivacaine + 0.5 ml saline and Group 2 was given 20 ml 0.5% plain bupivacaine + 1 μg/kg dexmedetomidine. Results: The time of sensory onset up to T10 was shorter in Group 2 (7.10 ± 2.10 min) as compared to Group 1 (15.02 ± 2.6 min). The time of motor block onset to bromage 3 was shorter in Group 2 (14.50 ± 5.18 min) as compared to Group 1 (20.36 ± 3.4 min). The time of motor block regression to bromage 0 was longer in Group 2 (248.70 ± 28.40 min) as compared to Group 1 (152 ± 12.2 min). The time of sensory block regression and the duration of analgesia were also longer in Group 2. Conclusion: Dexmedetomidine seems to be a good choice as an adjuvant with bupivacaine in epidural anesthesia.

A prospective study of incidence and assessment of Adverse Cutaneous Drug Reactions as a part of Pharmacovigilance from a rural northern Indian medical school.

Background: The wide and indiscriminate use of drugs has increased the incidence and the modes of presentation of cutaneous drug reaction. Understanding the nature of ACDRs may help narrow down the search for the offending agent. Aim- The study aimed to evaluate incidence, assessment of causality, severity and preventability of Adverse Cutaneous Drug Reactions as a part of Pharmacovigilance from a rural northern Indian medical school. Material and methods: The current survey was executed by the department of Pharmacology in collaboration with Department of Dermatology, MSDS Medical College, Fatehgarh among 7692 patients attending Dermatology OPD during March-December 2014. CDSCO ADR Reporting Form, WHO causality assessment scale, Hartwig and Siegel’s Assessment scale and Modified Schomock and Thronton’s preventability assessment scale were used as study tools. All the doctors, residents, interns and students were encouraged to notify any suspected ACDRs. Patients were screened and recruited if they presented with visible skin lesions suspected to be drug related. As per Modified Schumock and Thornton Scale, 43.5% of ACDRs were ‘Definitely preventable’ followed by ‘Probably preventable’ (30.4%) and ‘Not preventable’ (26.1%). Results: 23 patients (0.3%) were detected to have one or other type of ACDRs. Fixed drug eruption was most common form (34.8%) of ACDRs followed by Acneform eruption and Urticaria in 21.7% and 13% respectively among study subjects. The most common drugs responsible for ACDRs were prednisolone, betamethasone and isoniazid for Fixed drug eruption, while matronidazole, cotrimoxazole and paracetamol for acneform eruption. Antimicrobials, other steroids and NSAIDs were responsible for other spectrum of ACDRs. On assessment of Causality of ACDRs, it was noted that more than half (52.2%) of them fall under probable category. Severity assessment of ACDRs revealed that majority (65.3%) of them was moderate in nature. Conclusion: Awareness on part of the physician can help in timely detection of cutaneous reactions, thereby restricting damage from them. Pharmacovigilance activity is significantly effective in increasing the reporting of ADRs. Study with long-term follow-up and monitoring of the patients with bigger sample size is warranted.

A rapid appraisal of factors influencing utilization of primary eye health services among the residents in a rural community.

Background: Identification of factors affecting utilization of primary eye health services would help the government and other eye care providers to address inequity issues in their eye care program. Aim: Therefore this study was planned to find out barrier to utilization of eye health services among people living in rural western Uttar Pradesh. Material and methods: The current community based cross-sectional survey which involved both qualitative and quantitative methods, was conducted among the residents. A total of 216 study subjects participated in the study. Factors in the supply side influencing utilization of eye health services by people from the community were sought through Focus Group Discussion (FGD) and Key Informant Interview (KII). Results: Almost 80% of the respondents had agriculture as their major occupation and > 1/4th were from lower caste community. Regarding the seeking of eye care services, 52.4% respondents who gave a positive history of an eye problem in the family told they attended the nearest health facility; CHC, PHC or SC while 19.2% did actually go to the eye health center. Only 4.8% respondent did not seek any service. Among 112 respondents who were aware of one or other eye diseases, 74.6% identified dirty things fallen into the eyes as the cause of an eye problem followed by 50.3% of the respondents who pointed out injury to the eyes as the culprit. For emergency problem in the eyes 79.2% respondents told that they sought services from health facilities without delay, while 15.4% gave priority to starting household treatment. Conclusion: Raising awareness of the community about eye diseases and the services available together with strengthening of primary eye health services available at the local health facilities could help bring eye health services in closer proximity to the rural population.

A study on perceptions about eye health care and promoting factors for eye donation among medical students from a tertiary care teaching hospital.

Background: Voluntary eye donation depends on the awareness levels of various stakeholders in the community. Today’s medical students are tomorrow’s stakeholders of the community. Medical professionals can enhance eye donation rates by educating and motivating the relatives in case of patient's death. Aim: Hence the present study was undertaken with an objective of assessing the promoting factors for eye donation among medical students. Material and methods: The present descriptive cross sectional study was carried out among undergraduate students of a medical college in western Uttar Pradesh in the month of February 2014 using pretested self administered questionnaire. Results: 77% students knew about eye donation. 51% of them were willing to donate their eyes. Only 39% students knew that the ideal time for eye donation is within 6 hours of death. 64% had knowledge about vitamin A’s important role in prevention of childhood blindness. TV, newspaper or other media were the most important channels of getting information for majority (60%) of the students. Regarding perceived promoting factors for eye donation by them, noble cause (57%), pleasure to help the blind (51%) and inspired by advertisement on television (42%) were 3 top most promoting factors. Conclusion: Inclusion of different preventive and promotive aspects of corneal blindness along with basic eye health care into the course curriculum is the need of the hour.