Recent Advances in the development of Modified Release Tablets by amalgamating both Solubility Enhancement and Polymer Matrix Sintering Technologies.

Background: The fact that about 90 % of newly discovered API’s or new molecular entity(NME) have little or no aqueous solubility, causes a significant protest to the initialization of development and their scale up of dosage form in the Pharma Industry. Aqueous solubility of API’s has critical role in drug dissolution or availability of drug at the site of action or bioavailability, when a dosage form is administered orally.Objective: The object of this study is to formulate a modified release tablet dosage form of a poorly aqueous soluble drug, which not only have higher aqueous solubility or bioavailability but also have sustained release characteristics with high mechanical strength &their commercial viability. Numerous techniques are available for the solubility enhancement but all individual techniques have its own limitations for commercialization.Method: Aqueous solubility of drugs is improved by the known Solubility enhancement techniques like Micronization &Solid dispersions. After successful solubility enhancement, sustained release or modified release tablets of poorly aqueous soluble drug can be easily formulated into a suitable shape or size by using a known Polymer Matrix Sintering Technology with commercial feasibility. Micronization of poorly water-soluble drugs can be performed by Air Jet Mill or Ball Mill. Whereas Solid dispersion technique involves, molecular dispersion of poorly soluble drug in a suitable inert carrier, to form an amorphous and highly soluble compounds. Sintering Technology is defined as the bonding of adjacent particle surfaces in a mass of powder, or in compact, by the application of heat. Conventional sintering technique involves the heating of compact at a temperature below the melting point of the solid constituents in a controlled environment under atmospheric pressure.Results: Enhanced solubility of poorly soluble API’s by these proposed techniques is due to either conversion of crystalline compound in to amorphous form or reduction of particle size to its molecular level by the application of Micronization or solid dispersion techniques. The developed modified release tablets will show a sustained release characteristic due to Sintering aspect and provides enhanced solubility of BCS class II or IV drugs.Conclusion: Novel modified release tablets have been designed through consolidation of Solubility enhancement and Polymer Matrix Sintering technologies. Simultaneous exploitation of well-known and established approaches- Micronization (optimum particle size reduction) or solid dispersion, optional surfactant and Polymer Matrix Sintering Technique in the recent concept, produces significant enhancement of solubility of poorly water soluble API’s without compromising the content uniformity of dosage form and also provide a modified or sustained release characteristics with high mechanical strength. The release profile of drug can be easily tailored by using combination of both techniques where challenges of low solubility are prominent.

A Delphi consensus on the nomenclature and diagnosis of lichen planus pigmentosus and related entities

Background: Although well known in clinical practice, research in lichen planus pigmentosus and related dermal pigmentary diseases is restricted due to lack of consensus on nomenclature and disease definition. Aims and Objectives: Delphi exercise to define and categorise acquired dermal pigmentary diseases. Methods: Core areas were identified including disease definition, etiopathogenesis, risk factors, clinical features, diagnostic methods, treatment modalities and outcome measures. The Delphi exercise was conducted in three rounds. Results: Sixteen researchers representing 12 different universities across India and Australia agreed to be part of this Delphi exercise. At the end of three rounds, a consensus of >80% was reached on usage of the umbrella term ‘acquired dermal macular hyperpigmentation’. It was agreed that there were minimal differences, if any, among the disorders previously defined as ashy dermatosis, erythema dyschromicum perstans, Riehl’s melanosis and pigmented contact dermatitis. It was also agreed that lichen planus pigmentosus, erythema dyschromicum perstans and ashy dermatosis did not differ significantly apart from the sites of involvement, as historically described in the literature. Exposure to hair colours, sunlight and cosmetics was associated with these disorders in a significant proportion of patients. Participants agreed that both histopathology and dermatoscopy could diagnose dermal pigmentation characteristic of acquired dermal macular hyperpigmentation but could not differentiate the individual entities of ashy dermatosis, erythema dyschromicum perstans, Riehl’s melanosis, lichen planus pigmentosus and pigmented contact dermatitis. Limitations: A wider consensus involving representatives from East Asian, European and Latin American countries is required. Conclusion: Acquired dermal macular hyperpigmentation could be an appropriate conglomerate terminology for acquired dermatoses characterised by idiopathic or multifactorial non-inflammatory macular dermal hyperpigmentation

Patient perception and satisfaction with a smartphone-based teledermatology service initiated during the COVID-19 pandemic at a tertiary care hospital in North India

Background: Telemedicine is being increasingly used to provide healthcare to patients, particularly during the COVID-19 pandemic. Aims: The study aimed to study patient perception and satisfaction with a smartphone-based hybrid teledermatology service initiated during the COVID-19 pandemic. Methods: This was a cross-sectional telephonic survey including patients ?18 years of age who had received a teledermatology consultation. After noting the demographic, clinical and teleconsultation details, patients were administered the Telemedicine Satisfaction Questionnaire and an additional 6-item questionnaire. Patients were also asked to give qualitative feedback and suggestions for improvement using a semi-structured interview guide. Results: We interviewed 201 subjects. The most common diagnoses were pemphigus (27, 13.4%), superficial fungal infections (24, 11.8%), psoriasis (22, 10.9%) and dermatitis (21, 10.4%). The overall mean Telemedicine Satisfaction Questionnaire score was 4.20± 0.71. One hundred seventy-one (85.1%) patients responded that they would use teledermatology services again, while 168 (83.6%) reported satisfaction with the quality of services. A majority of the patients were largely satisfied with the various components involved, though some concerns were raised about the care perceived as not at par with physical consultations, difficulty in procuring medicines, lack of confidence in photographic diagnoses and the lack of a personal touch. Patients with urticaria (P=0.020), those who were advised a change in treatment (P=0.029) and those with improvement in their skin disease (P=0.026) were more likely to be satisfied. Limitations: Our study was conducted during the COVID-19 pandemic when patient acceptability was likely to be higher. Only follow-up patients were included in the study. Conclusion: Patient satisfaction levels were generally high with teledermatology. Addressing lacunae that negatively impact patient perception and satisfaction will help in greater acceptance of teledermatology services.

Establishment of SMS Dengue Severity Score

Background: Dengue infection is a disease that progresses rapidly to life-threatening conditions. Our goal was to develop a practical scoring system based on clinical profiles and routine tests to predict the severity of infection. Methods: This cross-sectional observational study included 500 patients with dengue infection. Patient demographics, clinical symptoms, regular laboratory tests, and results were collected. Dengue infections are divided into three classes, depending on their severity: dengue fever (DF), dengue hemorrhagic fever (DHF), and dengue shock syndrome (DSS). Based on the total score, patients were divided into three severities. Results: Patients with DSS and DHF scored higher with worsening clinical features and routine laboratory tests compared to DF. Clinical predictors of severity include older age, increased white blood cell (WBC) count, increased hematocrit, increased prothrombin time, decreased platelet count, decreased blood pressure, presence of peri-gallbladder (GB) edema, third space loss, hepatomegaly, and other organ involvement. The severity range is 0–12, and the score is 0–3 for DF, 4–8 for DHF, and 9–12 for DSS. Based on the derived scores, patients were classified according to their original severity in 63% of cases. Conclusion: This dengue infection severity scores correctly classified patients according to their original severity grade of DF, DHF, or DSS. This scoring system helps to quickly assess dengue infections and start treatment according to the correct severity category.

Profile of dermatology inpatients and admissions over a four year period in a tertiary level government teaching hospital in North India

Background: Although dermatology is mostly an outpatient specialty, some patients with severe skin disease need hospital admission for management. There is a paucity of data regarding the profile of these dermatology in-patient admissions. Aims: We studied the profile of patients admitted to the dermatology ward of our tertiary care government hospital in North India. Methods: This was a retrospective analysis of discharge sheets of patients admitted in the dermatology ward from January 1, 2014 to December 31, 2017. Results: Discharge sheets of 2032 admissions for 1664 patients were analyzed. The most common diagnoses in the admitted patients were immunobullous disorders (576, 28%), connective tissue diseases (409, 20%), infections, including leprosy and sexually transmitted infections (179, 8.8%), psoriasis (153, 7.5%) and reactive arthritis (92, 4.5%). The mean duration of admission was 13.95±11.67 days (range 1-118 days). Two hundred and fifty-six patients (15.38%) were re-admitted, accounting for 368 (18.11%) re-admissions. Patients with immunobullous disorders (OR 1.72, 95% CI 1.29-2.28) and psoriasis (OR 1.62, 95% CI 1.02-2.55) were more likely to be re-admitted. Adult patients, those who were admitted for more than four weeks, those who had comorbidities, and those who developed a complication during the hospital stay also had a greater likelihood of being re-admitted. Limitations: The retrospective design of the study, and the non-availability of data regarding transfers to other specialties or intensive care units and deaths were the main limitations of this study. Conclusion: This study describes the profile of patients admitted in a dermatology ward of a tertiary care centre center in North India. The patient profile and admission characteristics associated with a higher probability of re-admission were identified.

Significant correlation of ischemic stroke with peripheral artery disease in type 2 diabetes mellitus patients

Background:Atherosclerotic disease is not only increased in incidence in type 2 diabetic patients, but its course is also accelerated. Stroke is one of the major causes of morbidity and mortality among the elderly population. The relationship between ischemic strokeand PAD (peripheral artery disease) has been poorly investigated in India. So, we studied the risk of stroke in PAD patients with type 2 diabetes. The aims and objectives of the study were to study the prevalence of PAD in patients with type 2 diabetes mellitus and to study the correlation of stroke in PAD patients with type 2 diabetes.Methods:Hospital based cross-sectional study was conducted among the 124 patients admitted with type 2 diabetes (age >25 years) from December2019 to October2021 in the various units of department of medicine/surgery, KPS institute, GSVM medical college,Kanpur. Color Doppler of limbs and carotid artery was done in study population. Clinical sign and symptoms, history of stroke or diagnostic investigation were used for evaluate cerebrovascular events.Results:In our study based on doppler ultrasound, the prevalence of PAD was found in 31 patients (25%) out of 124 with men having a higher prevalence (24 out of 74; 77.4%), as compared to women (7 out of 50; 22.6%) (p=0.020). The prevalence of stroke was 32.3% in PAD patients and 11.8% in non-PAD patients (p=0.009).Conclusions:By using Doppler, we found evidence of PAD in 25% of type 2 diabetics (M>F). The prevalence of stroke was 32.3% in PAD patients and 11.8% in non-PAD patients (p=0.009). PAD is associated with an increased risk of cerebrovascular disease morbidity and mortality. Clinician should identify a PAD patient with diabetes to elicit symptoms, complications like stroke to decrease mortality or morbidity.

Prevalence of peripheral arterial disease in type 2 diabetes mellitus and it’s correlation with carotid intima-media thickness

Background:Peripheral arterial disease (PAD) is one of the major macrovascular complications of diabetes mellitus (DM) which is largely neglected by clinicians. DM-associated atherosclerosis can lead to complications in all major of vascular beds, including the coronary arteries, carotid vessels, and lower extremity arteries. Aims and objective were tostudy the prevalence of PAD in patients with type 2 DMand to study the correlation with carotid artery intima-media thicknessMethods:Hospital based cross-sectional study was conducted among the 124 patients admitted with type 2 diabetes (age >25 year) from Dec 2019 to Oct 2021 in the various units of department of medicineor surgery, KPS institute, GSVM medical college Kanpur. Color doppler of limbs and carotid artery was done in study population.Results:In our study based on doppler ultrasound, the prevalence of PAD was found in 31 patients (25%) out of 124 with men having a higher prevalence (24 out of 74; 77.4%), as compared to women (7 out of 50; 22.6%) (p=0.020). The mean Carotid IMT (mm) (Average) was 0.82±0.16 in all diabetics. Patients with PAD have more increase in CIMT (0.95±0.12) as compare to non-PAD (0.77±0.15) p<0.001.Conclusions:By using doppler, we found evidence of PAD in 25% of type 2 diabetics (M>>F). Patients with PAD have more increase in CIMT as compare to non-PAD.

Personal financial literacy among Indian postgraduate residents

BACKGROUND Postgraduate residents’ ability to understand and effectively manage their finances is variable. We conducted this study to assess the awareness of personal financial literacy among Indian residents. METHODS We circulated a web-based cross-sectional Google Forms multiple-choice questionnaire having questions in three categories including financial awareness, current financial status and plans among 400 Indian residents. RESULTS A total of 215 Indian residents (53.75%) responded to the survey (men 80.9%, unmarried 74.4% and pursuing broad specialties 83.3%). The majority were unaware of stocks, special student/doctor loans, tax planning, life insurance, professional indemnity and tax/financial planning. The majority opined that personal finance and investing should be taught at medical school/residency. A financial pyramid based on the hierarchy of needs is proposed. CONCLUSION Lack of financial literacy and planning was seen among the majority of Indian residents. Our study highlights this gap in the medical curriculum and the need for formal structured financial education during training.

Predictors of Outcome in Acute Respiratory Distress Syndrome in Acute Febrile Illness in Medical Intensive Care Unit

Aims: Acute Respiratory Distress Syndrome (ARDS) is a known complication of acute febrile illness (AFI). The in-hospital mortality rate of ARDS is between 35-44%. Our study aimed to identify the different parameters that could be used to detect patients at higher risk of poor outcome in AFI complicated by ARDS. Methods: 130 patients with AFI complicated by ARDS as per Berlin definition, admitted at the Medical Intensive Care Unit of Seth GS Medical College & KEM Hospital Mumbai, were studied over a period of 18 months. Investigations done during the course of MICU stay were noted. From the reports, SOFA score, delta SOFA score, Lung Injury Score (LIS), Disseminated Intravascular Coagulation (DIC) score (by ISTH scoring system) were also calculated. Main outcome was recorded as transfer out from the MICU or death. Results: Etiology of the 130 patients of AFI with ARDS was as follows-dengue 32 patients (24.6%), H1N1 -31(23.8%), undifferentiated fever -30 (23.1%), leptospirosis-22 (16.9%), malaria-15 (11.5%). Our study had a mortality rate of 25.4 %( n=33). 40.8% of the study population required invasive ventilation at admission. SOFA score at admission and 48 hours, delta SOFA score, PaO2/ FiO2 ratio at admission and 48 hours, Blood Urea Nitrogen (BUN), creatinine, bicarbonate and albumin were the significant predictors of overall outcome. Hemoglobin, platelets and leukocyte counts, pH, pO 2 , pCO 2 at admission and 48 hours, Lung Injury Score (LIS) and DIC score were not significant predictors of outcome. Conclusion: SOFA score at admission and 48 hours, delta SOFA score and PaO 2 / FiO 2 ratio were significant predictors of outcome in patients of acute febrile illness with ARDS. LIS and DIC score were not significant predictors of outcome.

Extra-pulmonary Manifestations of COVID-19 in Western India

Background: SARS-CoV-2 is well known disorder to affect respiratory system, although it can also influence several extrapulmonary organs through variety of pathological mechanism. In this study, we aimed to discuss the prevalence of atypical and/or extrapulmonary manifestations in COVID-19, therefor action for early isolation and diagnosis can be initiated to prevent spread of infection. Methods: This retrospective observational study included 4200 admitted COVID-19 patients. The patient’s data concerning medical history, clinical symptoms at presentation and during course of hospitalization, laboratory and radiological diagnosis and underlying chronic medical illness were extracted from their medical records. Data of extrapulmonary and/or atypical presentations of COVID-19 were compiled and tabulated to know prevalence of these manifestations. Results: In this study, 1260 patients (30%) had symptomatic presentation. Major extrapulmonary clinical manifestation includes fatigue in 72.22% patients, impaired sense of taste (ageusia) in 58.73%, loss of appetite in 52.78%, impaired sense of smell (anosmia) in 46.83%, palpitation in 33.33%, headache in 33.17%, nausea/vomiting in 31.43%, diarrhoea in 25.40% patients. Among symptomatic COVID-19 patients, 95.56% patients had sinus tachycardia, 38.49% had lymphocytopenia, 36.83% had hepatitis, 35.48% had leukopenia, 27.83% had gastroenteritis, 22.22% had sepsis, 20.87% had proteinuria, 17.30% had coronary artery disease and 16.34% had acute kidney injury in decreasing order. Prevalence of coagulation defect associated disorder were found to be deep venous thrombosis in 15.56% patients, acute coronary syndrome in 7.78%, brain infarct in 6.35%, pulmonary artery thrombosis in 3.25% and SMA thrombosis in 0.32% of symptomatic patients. Conclusion: Patients of SARS-CoV-2 had widespread organ-specific manifestations with involvement of almost all organ system of body. Clinicians must have knowledge of these extrapulmonary symptoms or atypical presentation of COVID-19 as it assists in early diagnosis, isolation of suspected patients and limit the transmission of infection in the hospital settings.

Biochemical markers as predictors of dengue severity

Background:The objective of this study was to evaluate biochemical markers as predictors of dengue severity clinical outcome, bleeding severity, capillary leakage, supportive therapy requirement and duration of hospital stay.Methods:In this observational study Patients from age more than 15 years with history of acute febrile illness Total 263 confirmed cases (based on the WHO criteria) of DF were included in this study, who have been admitted in our hospital. We measured levels of CK, LDH, AST and ALT with modified liquid-UV tests; semi-quantitative levels of CRP with a colorimetric rapid test; levels of albumin with colorimetric tests; and lipid profiles [cholesterol, triglycerides, Low-density lipoprotein (LDL) and High-density lipo-protein (HDL)] with a liquid-color test. Positive control human samples were included in all tests.Results:We found that TG and LDL-C levels were significantly lower in dengue-positive patients compared to dengue-negative patients, and that LDL-C levels showed greater decreases and thus appeared to drive the reduction in total cholesterol. LDH, CPK, AST and ALT were significantly raised in DSS in compared to DF and other febrile illness. We found that lower total serum cholesterol and LDL-C levels at presentation were associated with subsequent development of DHF/DSS.Conclusions:Assessment of lymphocyte, platelet counts, levels of LDL, TG, CPK, LDH, levels of AST and ALT are very significant and easily available and low-cost biochemical markers for prediction of dengue infection severity.

Lopinavir/ritonavir: is early administration better in Covid-19?

Background: To share the data of coronavirus 2019 (Covid-19) patients started on lopinavir-ritonavir (lopi/r) in relation to time period from the onset of symptoms.Method: Observational descriptive study of 23 Covid-19 patients admitted in a tertiary care center in India from March 2020 to May 2020. Patients categorized into 2 groups based on the timing of initiation of lopi/r from the onset of symptoms. Group 1 were given the drug early (≤7 days) and group 2 late (>7 days). The clinical events (oxygen requirement days and ICU stay) and outcomes of hospital stay between the two groups were evaluated.Results: Patients were started on lopi/r for a period of 14 days on admission, out of which 12 patients were in group 1 and 11 patients in group 2. Underlying co-morbidities were present in 15 patients (65.21%). The mean duration from onset of symptoms to lopi/r initiation was 4 days and 11.1 days in Group 1 and 2 respectively. Requirement for oxygen support (2.16 versus 6.54 days), mean duration of hospitalization (8.58 versus 11.54 days) and mean duration of obtaining first Covid-19 negative report from the onset of symptoms (10.5 versus 19.57 days) were all significantly lesser in group 1 (p<0.05). All patients belonging to Group 1 and eight patients of group 2 recovered completely and were discharged whereas 3 patients of group 2 expired. Diarrhea was the most commonly observed adverse effect of lopi/r in our patients.Conclusion: With no approved weapon to tackle the Covid-19 pandemic, we should keep lopi/r in our armamentarium of drugs and use it at the earliest. More clinical trials are needed in future to ascertain if lopi/r can reduce hospital stay, prompt faster recovery and result in better clinical outcome.

A study to investigate the prevalence of metabolic syndrome in Chronic Obstructive Pulmonary Disease patients from North India

Background: Worldwide, Chronic obstructive pulmonary disease (COPD) is the one of the leading cause of chronic morbidity and mortality. COPD is one of the diseases in which smoking is the common and important risk factor when it is associated with Metabolic syndrome (MetS). The individual components of MetS, i.e., obesity, dyslipidemia, fasting hyperglycaemia, and hypertension were independently associated with impairment of lung function too. The objective of this study is to find out the prevalence of metabolic syndrome among COPD patients.Methods: This was a cross-sectional study conducted in department of Respiratory Diseases and a total of 70 COPD patients were included in the study, which were enrolled for treatment from July 2016 to July 2017. The severity level in patients with COPD were determined according to GOLD (Global Initiative for Chronic Obstructive Lung Disease), 2015 guideline. International Diabetes Federation (IDF) guideline; (2005) was used in diagnosis of metabolic syndrome.Results: Seventy patients with COPD were enrolled during the study period. There were 45 males (64.2%) and 25(35.7%) females. Mean age of male patients was 58.67±9.87 years, while mean age of female patients was 57.23±10.4 years (35-87 years). Mean BMI of male was 24.33±6.64 kg/m2, while in case of female it was 30.07±6.95 kg/m2 and overall mean BMI of study population was 26.22±7.22 kg/m2. The mean   waist circumference of male was 86.91±13.31 cm while in female it was 87.18±14.51 cm. The Overall prevalence of metabolic syndrome was 31.34% and most common in GOLD stage-3 (47.06%), followed by stage-2 (40%), followed by stage-4 (25.71%) and 7.4 % in GOLD stage -1.Conclusions: The presence of metabolic syndrome is common in patients with COPD and, all COPD patients should be considered for screening for it.

Assessment of death registration coverage and its delays in district Faridkot: an urban rural comparison

Background: Death registration has been made compulsory under the RBD Act 1969 as it acts as a back bone for planning services and formulates policies. According to CRS 2013, at national level, 70.9% of deaths were registered which is far from magic figure of 100% despite of concerted efforts of government. So this study was conducted to assess the coverage of death registration and its delays. Methods: A cross sectional study was conducted over a period of one year where 332 households(166 each from urban and rural area reporting deaths in last two years were included in study after taking informed written consent. Relevant information was collected using a predesigned and pretested questionnaire by house to house survey. Coverage was calculated with possession of death certificate. Data was compiled and analyzed using EpiInfo07 (CDC, Atlanta, USA). Results: Out of 332 deaths, 245 (74%) out of which only140 (57%) possessed the death certificate. The main cause of death was cardiac diseases. Maximum coverage was seen in the age group 41-60 years. Delay in registration was seen in 48% with significantly higher proportion in rural area (59%) than in urban area (40%). Reasons for delay were time constraints, lack of knowledge and financial constraints. Socio demographic variables like religion, caste, type of family, family size and SES were not found to be associated with delay. Conclusions: The coverage of death registration was comparatively higher than national data and delay was observed in about half of the death registration coverage