Formulation and evaluation of itraconazole-loaded nanoemulgel for efficient topical delivery to treat fungal infections.

Aim: The clinical application of conventional oral dosage form of itraconazole is limited due to its poor bioavailability. The aim of the study was to develop nanoemulgel of Itraconazole for topical delivery. Method: Nanoemulsions were prepared, optimized and further incorporated into a gel and evaluated for homogeneity, pH, viscosity, spreadability, in vitro drug release and skin irritation studies. Results: Cumulative drug release from nanoemulsions was within the range of 37.24 to 47.63% at 10 h. Drug release % for all the nanoemulgel formulations at10 h was 32.39, 39.75 and 45.9% respectively. Nanoemulgel was non-irritant as demonstrated by skin irritation studies in animals. Conclusion: Itraconazole nanoemulgels were proved to be potential for effective topical delivery of drug with enhanced bioavailability.

Intranasal administration of innovative triamcinolone acetonide encapsulated cubosomal in situ gel: formulation and characterization.

AIM: The primary objective of the research was to develop a cubosomal in situ gel encapsulated with Triamcinolone acetonide (TCA) in order to enhance its penetration through the blood-brain barrier (BBB) when administered via the intranasal route, thus enabling efficient and rapid action. METHOD: Cubosomes were formulated by top-down approach using glyceryl monooleate (GMO), using pluronics127 (PF127) and polyvinyl alcohol (PVA) in varying proportions based on the Box-Behnken design. High resolution transmission electron microscopy (HR-TEM) analysis confirmed the morphology of the cubosomes. The in situ gel was formulated and optimized. Experiments involving ex vivo permeation and histopathology analyses were undertaken to evaluate drug permeation and tissue effects. RESULTS: The cubosomes exhibited a particle size (PS) of 197.9 nm, zeta potential (ZP) of -31.11 mV, and entrapment efficacy (EE) of 84.31%, with low deviation. Batch F4 (19% PF127) showed favorable results. In vitro and ex vivo permeation studies revealed drug release of 78.59% and 76.65%, respectively, after 8 h. Drug release followed the Hixson Crowell model of release kinetics. The histopathological examination revealed no signs of toxicity or adverse effects on the nasal mucosa of the sheep. The formulation exhibited short-term stability, maintaining its integrity and properties when stored at room temperature. CONCLUSION: The utilization of an intranasal cubosomal in situ gel encapsulated with TCA was anticipated to lower intracranial pressure and improve patient adherence by offering effective relief for individuals suffering from Brain edema. This efficacy is attributed to its rapid onset of action and its safe and well-tolerated dosage form.

In situ gastric floating gel of atazanavir sulphate for sustained release: formulation, optimization and evaluation.

Aim: Atazanavir sulphate belongs to BCS class II drug, its oral bioavailability is limited due to its rapid first-pass metabolism and P-gp efflux. Materials & methods: The in situ floating gel using the complexed drug was prepared by ion gelation method and optimized the formulation as per 32 full factorial design. Results: Floating lag time of optimized formulation was found to be 18 s and percentage drug release of 94.18 ± 0.18 % at the end of 16 h. The concentration of gelling polymer affects drug release and a floating lag time and vice versa. Conclusion: In situ floating gel of atazanavir sulphate was found promising to sustain drug release due to an increased gastric residence time, which leads to enhanced potential therapy.

In our study, we wanted to create a gel for a medicine called atazanavir sulphate. This gel can float in the stomach for a long time and slowly release the medicine. We mixed atazanavir sulphate with something called ß-cyclodextrin, and this mixture made the medicine dissolve better in water. We used this mixture to make our floating gel, which can stay in the stomach without sinking. Our gel can make the medicine work better because it dissolves well and stays in the stomach for a long time. This means the medicine can help people for a longer period.

Edifications on Indirect IgM ELISA and Immunofluorescence assay (IFA) of scrub typhus in humans and erudition of Orientia tsutsugamushi in the vector of cohabiting rodents.

Scrub typhus is a vector-borne disease caused by Orientia tsutsugamushi, propagated into humans by the bite of infected mite belonging to genus Leptotrombodium. The present study was conducted in the Nagpur region of central India aiming towards a survey of cohabiting rodents and their potential vectors for the presence of Orientia tsutsugamushi by PCR method. The study also emphasizes serological diagnosis of the disease by employing indirect IgM ELISA and IFA amongst the human cases of pyrexia of unknown origin. Indirect IgM ELISA recorded 39.69% (31/92) seropositive patients, further processing of ELISA positive samples for IFA revealed 67.74 % (21/31) positivity for Boryong, Gilliam, Karp, and Kato serotypes. A total of 50 rodents were trapped from the cohabit areas of the patients. Three different types of rodents were identified; among which, Rattus bandicoot was highest. From these rodents, 164 vectors viz mites, lice, and fleas were collected. The highest chiggar index was recorded for Ornithonyssus biscotti mites (3.4). This study prompts a detailed analysis of different species of rodents and vectors in the said endemic region.

A comprehensive review on pharmaceutical excipients.

The effectiveness of pharmaceutical drugs depends not only on their active components and manufacturing processes, but also on the role played by pharmaceutical excipients. The traditional definition of excipients as inactive and cost-effective substances has evolved significantly. They are now recognized as essential elements of drug formulations, constituting 80-90% of the final product. The rapid advancements in delivery systems, along with scientific, regulatory, financial and technological developments in biopharmaceutics, have generated renewed interest in the use and functionality of excipients, especially in solid dosage forms. This review focuses on the categorization of excipients according to the International Pharmaceutical Excipient Council (IPEC) and the establishment of guidelines for evaluating the safety of a new proposed excipient.

Excipients are matter we add to medicine when we make it. They give the medicine different qualities, like making it easier to dissolve, stick together, or slide smoothly. But if we use too many excipients, it can make the medicine less stable and more expensive. To avoid these problems, we can use special excipients that can do more than one thing. These multi-purpose excipients make the medicine work better, stay stable and cost less.

Fabrication, Optimization, and Evaluation of Transdermal Patch: As an Alternative and Effective Transdermal Delivery System for Nebivolol HCl.

BACKGROUND: Nebivolol HCl is a unique third-generation beta blocker that has less oral bioavailability and exhibits various adverse effects like gastrointestinal disturbance and abdominal pain. OBJECTIVE: This study aimed to formulate and evaluate nebivolol HCl transferosomal transdermal patches to reduce the problems associated with oral delivery of the drug and enhancement of drug permeation through the skin. METHODS: Nebivolol HCl loaded transferosomes were prepared by thin film hydration method. Eight formulations were prepared based on the two independent variables, type of surfactant (Tween 80 and Span 80) and Phospholipid: Edge activator ratio and were evaluated for their vesicle size, PDI, and entrapment efficiency. The optimized formulations were incorporated into transdermal patches, which were evaluated for physicochemical properties, in-vitro and ex-vivo permeation, skin irritancy, and stability studies. RESULTS: The vesicle size of the transferosomes ranged from 49nm to 93nm, and EE% varied from 39% to 79%. Vesicles formed with Span 80 as an edge activator showed smaller vesicle size and greater EE% as compared to Tween 80. Based on the results, TW4 and SP4 were selected as the optimized formulations for further incorporation into the transdermal patches. In-vitro and ex-vivo permeation studies showed permeation in the order F2 > F3 > F1, indicating that transferosomal formulations showed superior permeation of the drug compared to plain Nebivolol HCl patches. Span 80 transferosomes showed a slightly better permeation than Tween 80. Stability studies showed that transferosomes and the transdermal patches demonstrated good stability under proper storage conditions. CONCLUSION: The study concluded that transferosomal patches of Nebivolol HCl could be used as a potential approach with effective transdermal delivery for the management of hypertension.

Proanthocyanidin biosynthesis in the developing wheat seed coat investigated by chemical and RNA-Seq analysis.

The composition of proanthocyanidins in the testa (seed coat) of bread wheat was analyzed by thiolysis of PA oligomers from developing grain and found to consist of (+)-catechin monomers, with a small amount of (+)-gallocatechin. The average chain length of soluble PA stayed relatively constant between 10 and 20 days post-anthesis, whereas that of unextractable PA increased over the same period, suggesting that increases in chain length might account for the insolubility of PAs from mature wheat grain. We carried out RNA-Seq followed by differential expression analysis from dissected tissues of developing grain from red- and white-grained near-isogenic lines differing in the presence of an active R gene that encodes a MYB transcription factor involved in control of PA biosynthesis. In addition to genes already identified encoding chalcone synthase, chalcone isomerase, flavanone 3-hydroxylase, and dihydroxyflavonoid 4-reductase, we showed that wheat genes encoding phenylalanine ammonia lyase, flavonoid 3',5'-hydroxylase, leucoanthocyanidin reductase, and a glutathione S-transferase (the orthologue of maize Bronze-2) were more highly expressed in the red NIL. We also identified candidate orthologues of other catalytic and regulatory components of flavonoid biosynthesis in wheat.

Perceptions of and challenges faced by primary healthcare workers about preconception services in rural India: A qualitative study using focus group discussion.

Background: Providing preconception care through healthcare workers at the primary health care level is a crucial intervention to reduce adverse pregnancy outcomes, consequently reducing neonatal mortality. Despite the availability of evidence, this window of opportunity remains unaddressed in many countries, including India. The public health care system is primarily accessed by rural and tribal Indian population. It is essential to know the frontline healthcare workers perception about preconception care. The study aimed to identify barriers and suggestions for framing appropriate strategies for implementing preconception care through primary health centers. Methods: The authors conducted a qualitative study using focus group discussions (FGDs) with 45 healthcare workers in four FGDs (8-14 participants in each), in four blocks of Nashik district. The transcribed discussions were analyzed in MAXQDA software using the Socio-Ecological Model as an initial coding guide, including four levels of factors (individual, interpersonal, community, and institutional) that influenced an individual's behavior to use preconception care services. Results: Healthcare workers had some knowledge about preconception care, limited to adolescent health and family planning services. The interpersonal factors included heavy workload, stress, lack of support and co-operation, and paucity of appreciation, and motivation. The perceived community factors included poverty, migration, poor knowledge of preconception care, lack of felt need for preconception services, the influence of older women in the household decision, low male involvement, myths and misconceptions regarding preconception services. The identified institutional factors were lack of human resources, specialized services, logistics, and challenges in delivering adolescent health and family planning programs. Healthcare workers suggested the need for program-specific guidelines, training and capacity building of human resources, an un-interrupted supply of logistics, and a unique community awareness drive supporting preconception care services. Conclusion: Multi-level factors of the Socio-Ecological Model influencing the preconception care services should be considered for framing strategies in the implementation of comprehensive preconception care as a part of a continuum of care for life cycle phases of women.

Prevalence of preconception risk factors for adverse pregnancy outcome among women from tribal and non-tribal blocks in Nashik district, India: a cross-sectional study.

BACKGROUND: Although critical, the preconception phase in women's lives is comparatively ignored. The presence of some risk factors during this phase adversely affects the wellbeing of the woman and the pregnancy outcome. The study objectives were to measure the prevalence of various known risk factors for adverse pregnancy outcome in the preconception period of women and their comparison between blocks. METHODS: This was a community-based cross-sectional study in two tribal and two non-tribal blocks each in Nasik district, Maharashtra, India. The study included married women desiring to conceive within 1 year. Trained Accredited Social Health Activists (field level health worker) collected information from women using a validated interview schedule through house-to-house visits and obtained women's anthropometric measurements in a standard manner. The study assessed the presence of 12 documented risk factors. RESULTS: The study enlisted 7875 women desiring pregnancy soon. The mean age of women was 23.19 (± 3.71) years, and 16% of them were adolescents. Women's illiteracy was higher in tribal areas than non-tribal (p < 0.001). About two-thirds of women have at least one risk factor, and 40.0% have a single risk factor. The most common risk factor observed was no formal education (44.35%). The prevalence of selected risk factors was significantly higher among women from tribal areas. The mean BMI of women was 19.73 (± 3.51), and a higher proportion (40.5%) of women from tribal areas had BMI < 18.5. Despite being of high parity status (≥ 4), about 7.7% of women from the tribal area and 3% from non-tribal desired pregnancy. Tobacco and alcohol consumption was higher among tribal women. The majority of women consumed meals with family members or husbands. Protein and calorie intake of about 1.4% of women was less than 50% of the recommended daily allowance; however, most of them perceived to have abundant food. CONCLUSIONS: Health risks, namely younger age, illiteracy, high parity, consumption of tobacco, low protein, and calorie intake, were quite prevalent, and the risks were significantly more among women from tribal areas. "Continuum of care" must comprise preconception care inclusive of Behavioral Change Communication, particularly for easily modifiable risk factors and specially for tribal women.

Women's health during the preconception phase although important, is an ignored period in her life cycle. Literature has shown that the presence of risk factors in women during the preconception phase is hazardous to the health of women and newborns. The present study is a cross-sectional study conducted in four blocks of Nasik district, Maharashtra, India, to measure risk factors for adverse pregnancy outcome among women and its comparison between blocks.We included married women desiring conception within 1 year. Accredited Social Health Activists asked questions using a validated interview schedule and recorded women's anthropometric measures.Of the 7875 women, 16% were adolescents, and the mean age of women was 23.19 ± 3.71 years. About two-fifth of women had one risk factor, the commonest being no formal education. Overall mean BMI of women was 19.73 (± 3.51). The prevalence of risk factors was significantly higher among women from tribal areas. Despite having ≥ 4 parity a higher proportion of women from tribal areas desired to conceive. About 1.4% of women had protein and calorie intake below 50% recommended consumption.In conclusion, the prevalence of selected risk factors was significantly higher among tribal women. The study identifies the need for preconception care services.

Formulation, optimization and validation of floating oral in situ gel of Ivabradine hydrochloride.

Aim: Ivabradine hydrochloride is a hyperpolarized activated channel blocker used for symptomatic treatment of chronic angina pectoris. However, due to its short half-life it is rapidly eliminated from systemic circulation. Materials & methods: Floating in situ gel was formulated using sodium alginate and HPMC K 100 M by pH induced ion gelation technique employing 32 factorial design for optimization and evaluated. Results: The in situ formulation remained buoyant in gastric environment for 12 h. Optimized formulation sustained and prolonged drug release in comparison with marketed product. Kinetic analysis of drug release indicated non fickian mechanism. Short term stability studies showed no significant changes indicating good formulation stability. Conclusion: Formulated in situ solution shows potential effective sustained release over a prolonged period of time.

Relative risk of postpartum maternal morbidity among cesarean-delivered women: A multisite prospective cohort study in a large district, India.

Introduction: Family doctors manage mild to moderate postpartum morbidities that do not receive attention. The morbidities are higher after cesareans, which are increasing in number. The aim was to calculate the relative risk of various maternal morbidities occurring during 6 months postpartum among cesarean-delivered women in Pune District, India. Material and Methods: This was a large multisite study, which included all 11 non-teaching government hospitals performing at least five cesarean sections per month, one teaching government hospital, and one private teaching hospital. All eligible cesarean delivered and an equal number of age and parity matched vaginally delivered women were the participants. The obstetricians interrogated women before discharge, after 4 weeks, 6 weeks, and 6 months. Results: In this study 3,112 women participated. At any visit and among any group lost to follow-up proportion was <10%. There was no major intra-operative complication among vaginally delivered women. The relative risks of acute and severe morbidity as intensive care unit admission and blood transfusion among cesarean-delivered women were 2.59 [95% confidence interval (CI) = 1.96 to 3.44], 4.33 (95% CI = 2.17 to 8.92), respectively. The adjusted relative risk of surgical site pain and infection at 4 weeks; surgical site pain at 6 weeks; and lower abdominal pain, breast engorgement/mastitis, urinary incontinence, and weakness at 6 months among cesarean-delivered women was higher (P < 0.05). Vaginally delivered women resumed family activities earlier. Conclusion: Health care workers, including family doctors, during follow-up of cesarean-delivered women, must assess for pain, induration/discharge at the surgical site, urinary incontinence, and breast engorgement/mastitis.

Meager Perception of Preconception Care Among Women Desiring Pregnancy in Rural Areas: A Qualitative Study Using Focus Group Discussions.

Background: India has the second-highest number of under-five deaths in any country in the world. WHO and the Government of India recommended the rollout of preconception care (PCC) to reduce maternal and child mortality. However, very few countries, including India, have started a comprehensive package of PCC services. It implies that women, mainly from rural and tribal areas, are not aware of PCC. PCC has been rolled out through the government health system in two blocks of Nashik district in Maharashtra state, India, among all women who desire to be pregnant within 1 year. This project is the first of its kind in India. To assess basic perceptions, knowledge, and behavior of women on PCC before the implementation of the project, focus group discussions (FGDs) were carried out. The authors think that the finding may help to develop strategies for behavioral change communication. Methods: From each of the four blocks, two villages having subcenter were selected for conducting FGD. A house-to-house survey was conducted by Accredited Social Health Activist (ASHA) to enlist women who desire a baby in 1 year and invite them to subcenter for FGDs, which were conducted in June 2018. Results: A total of 76 women having a mean age of 23.97 years participated in the FGDs. Most of them (46.05%) had completed 10 years of education. About 50% of pregnancies were planned. The decision about the timing of the first pregnancy is influenced by the mother-in-law. Women knew that they should not conceive before 20 years of age, and their suboptimal weight may have an adverse impact on the health of the newborn. There are many myths about food like "hot and cold foods" and "forbidden food" etc. Women had some knowledge about the adverse effects of tobacco and alcohol; very few consumed these. Most of them did not practice behaviors or accessed services related to PCC. Conclusions: Women neither have the knowledge nor adopt behaviors or accessed services related to PCC. Roll out of PCC among them may help in further reduction of maternal and neonatal morbidity and mortality in India.

Association between adverse pregnancy outcomes and preceding risk factors: a cross-sectional study from Nashik District, India.

BACKGROUND: The preconception phase of women's life cycle is critical but comparatively ignored. The presence of health risks is judged as hazardous to the wellbeing of women and their offspring. This study aimed to estimate the prevalence of various pregnancy outcomes and assess the association between certain risk factors and adverse outcomes. METHODS: As a part of a preconception care intervention project, a baseline survey was conducted in four blocks of Nashik District, India. In this population-based cross-sectional analytical study, we compared cases in the study group (randomly selected one tribal and one non-tribal block) with those of the control group (one tribal and one non-tribal block). A comparison was also made between the tribal and non-tribal blocks in each group. All women who had a pregnancy outcome in the preceding 12 months (01 April 2017 to 31 March 2018) were interviewed. Trained Accredited Social Health Activists conducted the survey under the direct supervision of Auxiliary Nurse Midwives and Medical Officers. Multivariate analysis was carried out to find the adjusted prevalence ratio of having a particular adverse outcome because of the prespecified potential risk factors. RESULTS: A total of 9307 women participated in the study. The prevalence of adverse pregnancy outcomes was as follows: abortion in 4.1%, stillbirth in 1.7%, preterm birth in 4.1%, low birth weight in 13.2%, and congenital physical defect in 2.8%. Prevalence of parental consanguinity, pre-existing maternal illness at conception, heavy work during the last six months of pregnancy, tobacco consumption, alcohol consumption, direct exposure to pesticides and domestic violence during pregnancy was 18.5, 2.2, 18.7, 5.6, 0.5, 2.3, and 0.8% respectively. Risk factors associated with abortion included pre-existing illness and heavy work in the last six months of the pregnancy. Consanguinity, tobacco consumption during pregnancy and pre-existing illness were identified as risk factors for stillbirth. Significant risk factors of low birth weight were heavy work in the last six months of pregnancy, pre-existing illness and residence in a tribal area. CONCLUSION: There is a need to emphasize on maternal behaviour, including tobacco consumption, and heavy work during pregnancy, as well as on parental consanguinity and pre-existing maternal illnesses, in order to achieve the best possible pregnancy outcomes.

Exploring the Solvent-Anti-solvent Method of Nanosuspension for Enhanced Oral Bioavailability of Lovastatin

Objectives: Lovastatin is an antilipidemic drug that belongs to the class of statins that has poor oral bioavailability due to its low solubility and variable dissolution rate. The main aim of this study was to enhance the solubility and dissolution rate of the drug and understand its oral bioavailability. Materials and Methods: Lovastatin nanosuspension was formulated using a solventanti-solvent method using a probe sonication technique. A nanosuspension was prepared, using hydroxypropyl methylcellulose (HPMC) K15M and pluronic F68 as stabilizers. The formulated nanosuspensions were characterized for particle size, polydispersity index (PDI) zeta potential, surface morphology, and in vitro release rate. Further, an in vivo bioavailability study and stability studies were also performed. Results: Optimized formulation showed a particle size of 127±0.01 nm, a PDI of 0.492±0.001, and a zeta potential of -37.9 mV, which indicates good stability. Morphological study showed that the particles were in the nano range. The drug content was found to be in the range of 73-87%. In vitro release revealed much faster release of the drug in one hour compared to the pure drug and its marketed formulation. In vivo bioavailability study was carried out in Wistar rats, which showed improvement in bioavailability by approximately 2.5 folds compared with the marketed formulation. Stability studies indicated that the optimized formulation F2 was more stable at 4°C±2°C. Conclusion: The prepared lovastatin nanosuspension showed improvement in solubility, dissolution rate, and oral bioavailability compared to the pure drug and its marketed formulation. Hence, lovastatin nanosuspension may be a potentially valuable tool for improving the oral bioavailability of lovastatin.

Assessment of difference in postpartum depression among caesarean and vaginally delivered women at 6-week follow-up in hospitals in Pune District, India: an observational cohort study.

OBJECTIVES: To compare the proportion of postpartum depression at 6 weeks among women who had caesarean delivery and women who had vaginal delivery and to assess its association with some sociodemographic factors. DESIGN: This is a descriptive comparative study with prospective enrolment. We followed the enrolled women and assessed them for postpartum depression 6 weeks after delivery. SETTING: We conducted the study in Pune District, India from July 2017 to December 2018. The study sites were all non-teaching government hospitals performing five or more caesarean sections per month and two teaching hospitals: one government and one private. PARTICIPANTS: We included in the study group women who have undergone caesarean section in the participating hospitals and were residents of Pune District. Women who delivered vaginally and matched in age and parity were included in the comparison group. We followed 1556 women in each group. MAIN OUTCOME MEASURES: An Edinburgh Postnatal Depression Scale score of 10 or more for each woman was the primary outcome. χ2 test and multivariable binary logistic regression were performed to assess the effect of mode of delivery on postpartum depression. RESULTS: The proportion of postpartum depression at 6 weeks was 3.79% among women who had caesarean delivery and 2.35% among those who had vaginal delivery (χ2=4.50, p=0.03). The adjusted OR was 1.86 (95% CI 1.14 to 3.03). Women of age less than 25 years had higher risk of postpartum depression. The adjusted OR was 2.10 (95% CI 1.21 to 3.65). The study did not observe any association between postpartum depression and income, education, occupation or sex of the newborn child. CONCLUSIONS: We conclude that young women particularly those who had caesarean delivery should be screened 6 weeks after delivery.

Risk of non-resumption of vaginal sex and dyspareunia among cesarean-delivered women.

CONTEXT: Many women have postpartum sexual dysfunction. The mode of delivery is an important determinant. AIMS: To calculate the risk ratio of non-resumption of vaginal sex and dyspareunia during the postpartum period among cesarean-delivered women. SETTINGS AND DESIGN: This large multisite study was conducted in 13 selected hospitals in Pune District during 2017-19. METHODS AND MATERIAL: A total of 3,112 women (half cesarean delivered and half vaginally) were interviewed by trained health workers using a structured questionnaire. Women were interviewed at 4 weeks, 6 weeks, and 6 months. STATISTICAL ANALYSIS USED: Chi-square test was applied. A risk ratio with a 95% confidence interval was calculated. RESULTS: At 6 weeks, the risk ratio of non-resumption of vaginal sex was significantly high among cesarean-delivered participants (1.14). Cesarean-delivered women had a lesser risk ratio of dyspareunia at both follow-ups (0.59, 0.49). Even at 6 months, about one-third vaginally delivered women had dyspareunia. The proportion of women non-resuming vaginal sex gradually decreased from 6 weeks to 6 months. The proportion of women having dyspareunia also decreased from 6 weeks to 6 months following childbirth. Residence in the rural area and cesarean delivery were the significant determinants of an early resumption of vaginal sex. Dyspareunia was significantly high among vaginal delivered than cesarean. About 25% of women continued to have dyspareunia up to 6 months. CONCLUSIONS: A large number of women suffer from dyspareunia; hence antenatal and postnatal care should include some counseling and management about the resumption of sex and dyspareunia.

Significant treatment gap and co-morbidities identified in an epidemiological survey of pediatric epilepsy in rural suburbs of India.

PURPOSE: A cross-sectional epidemiological survey of children was conducted in two rural clusters to estimate the point prevalence and study various aspects of childhood epilepsy. MATERIAL AND METHODS: In the first stage, a house-to-house survey was conducted by health workers using a screening questionnaire, which was pre-validated in a pilot study. All screen positive houses were visited by pediatric neurologist for detailed evaluation. Children with a clinical diagnosis of epilepsy underwent EEG and were evaluated for type of seizure, epilepsy syndrome, etiology, co-morbidities and treatment gap. Knowledge, attitude and practice regarding epilepsy was assessed amongst caregivers of the affected children. RESULTS: A total population of 75,455 population was screened, 19,181 children aged 2 months to 18 years were identified. Out of 355 screen positive children, 66 were diagnosed with epilepsy. The point prevalence of pediatric epilepsy was 3.44 per 1000 children. 53% had focal epilepsy, 31.8% had an identifiable epilepsy syndrome, 44% had at least one comorbidity. The etiology was identified in 68%, the commonest being perinatal brain insult. The magnitude of treatment gap was 45.45%, with significant deficits in knowledge. CONCLUSION: There are significant deficits in diagnosis and treatment of pediatric epilepsy among the rural population of India. The existing rural health care facilities need to be augmented to facilitate the timely diagnosis and optimum care of these children, including care of associated co-morbidities.

Nanostructured lipid carrier-incorporated gel for efficient topical delivery of fluconazole.

Background: Nanostructured lipid carriers (NLCs) of fluconazole were prepared to improve permeability and thereby effective topical drug delivery. Materials and methods: NLCs were prepared and evaluated, and then the optimized NLC suspension was incorporated into a gel that was further evaluated for topical drug delivery. Results and discussion: F-2 NLC formulation was optimized based on results of particle size (161.3 ± 1.385 nm), polydispersity index (0.401), zeta potential (-33 ± 0.46), entrapment efficiency (82.26 ± 0.91%) and in vitro drug release (76.40 ± 0.21%). Ex vivo skin permeation studies showed flux of F-2 gel and the comparison marketed gel as 0.21 and 0.18 mg/cm2/h, respectively. The in vitro antifungal study revealed significantly better activity compared with the marketed gel. Conclusion: Fluconazole NLCs increase drug permeability and proved to be effective in topical drug delivery.

Feasibility of implementation of simplified management of young infants with possible serious bacterial infection when referral is not feasible in tribal areas of Pune district, Maharashtra, India.

INTRODUCTION: Neonatal infections are a common cause of death in India, but many families cannot access appropriate hospitals for its treatment due to various reasons. We implemented the World Health Organization PSBI management guideline when referral is not feasible within the public health system in Pune, India to evaluate feasibility, barriers and facilitators for its implementation. METHODS: A national-level consultative meeting between government officials and study partners resulted in a consensus on adaptation and implementation in four demonstration sites in selected states in India. At the state and district levels, similar meetings to plan the implementation strategy and roles were held between KEM Hospital Research Centre (KEMHRC) Pune and the public health system Pune, Maharashtra. The public health system was responsible for implementation of the intervention at eight tribal primary health centres (PHC) in Pune district, India, including delivering the intervention and ensuring supplies of all commodities while KEMHRC was responsible for technical support including training of health workers, assistance in PSBI identification and management, data collection and documentation of the implementation strategy. RESULTS: A total of 175 young infants with PSBI were identified and managed. Of these, 34 had critical illness (CI), 46 had clinical severe infection (CSI) and 10 were infants aged 0-6 days with fast breathing (FB) while 85 infants aged 7-59 days had fast breathing. Assuming a 10% incidence of PSBI among all live births, with 3071 live births recorded, the actual incidence of PSBI found in the study was 5.7%, resulting in an actual coverage was of 57%. Among the 90 infants with CI, CSI and FB in 0-6 days, who were advised referral to government tertiary care centre as per the PSBI guideline algorithm, 81 (90%) accepted referral while 9 (10%) refused and were offered treatment at primary health centres (PHC) with a seven-day course of injectable gentamicin and oral amoxicillin. All infants with FB in 7-59 days were offered treatment at PHCs as per the PSBI guideline algorithm with a seven-day course of oral amoxicillin. All except six infants who died and one with FB in 7-59 days, who was lost to follow-up, were successfully cured. Of the six who died, five had CSI and one had CI. Among the 81 infants with CI, CSI and FB in 0-6 days who accepted referral; 48(53%) were successfully referred to government tertiary facility while 33 (36.6%) preferred to visit a private tertiary health facility. The implementation strategy demonstrated a relatively high fidelity, acceptance and intervention penetration. Lack of training and confidence of the public health staff were major challenges faced, which were resolved to a large extent through supportive supervision and re-trainings. CONCLUSION: Management of PSBI is feasible to implement in out-patient facilities in the public health system, but technical support to the health system is required to jump-start the process. Fast breathing in 7-59 days old infants can be managed with oral amoxicillin without referral. A sustainable adoption of this intervention by the health system can lead to decrease in neonatal mortality and morbidity.