A qualitative study to understand sociocultural beliefs around perinatal and neonatal health in rural areas of Mohali, Punjab, India.

Introduction: Globally, 600,000 mothers (15-49 years) die every year due to pregnancy and childbirth-related complications. Wide variations are seen in cultural practices and beliefs surrounding this period of a woman's life. The present study explores the cultural beliefs and practices of women and families during pregnancy and the postnatal period in order to understand what behavioral management strategies are required to improve maternal and infant outcomes during pregnancy and the postpartum period. Methods: The study was conducted in a rural area of Punjab, from December 2019 to March 2021. A total of 20 women (up to 3 months postpartum, age >18 years, were interviewed. Results: In general, women described eating varied and fairly healthy diets during pregnancy, especially nutritious warm food, following traditional practices. Other cultural practices included restrictions on movement and mobile phone use and the use of unsafe home remedies to promote infant safety and wellbeing, such as using gripe water, applying black pencil to the baby's eyes, and feeding the baby honey. A few were not inclined to engage with these and other cultural expectations, preferring instead to follow contemporary practices influenced by social media. These practices included being accompanied by a family member during delivery, celebrating the baby's birth regardless of sex, and early bathing post-delivery. Discussion: It can be concluded that while many traditional practices are still followed in India, there are new beliefs and behaviors arising from an intersection between culture and technology. Developing strategies that acknowledge older beliefs and modern approaches is essential to promoting better antenatal and postpartum care.

Targeted Delivery of Natural Bioactives and Lipid-nanocargos against Signaling Pathways Involved in Skin Cancer.

At present, skin cancer is considered a widespread malignancy in human beings. Among diverse population types, Caucasian populations are much more prone to this malignancy in comparison to darker skin populations due to the lack of skin pigmentation. Skin cancer is divided into malignant and non-melanoma skin cancer, which is further categorized as basal and squamous cell carcinoma. Exposure to ultraviolet radiation, chemical carcinogen (polycyclic aromatic hydrocarbons, arsenic, tar, etc.), and viruses (herpes virus, human papillomavirus, and human T-cell leukemia virus type-1) are major contributing factors to skin cancer. There are distinct pathways available through which skin cancer develops, such as the JAK-STAT pathway, Akt pathway, MAPKs signaling pathway, Wnt signaling pathway, to name a few. Currently, several targeted treatments are available, such as monoclonal antibodies, which have dramatically changed the line of treatment of this disease but possess major therapeutic limitations. Thus, many phytochemicals have been evaluated either alone or in combination with the existing synthetic drugs to overcome their limitations and have been found to play a promising role in the prevention and treatment. In this review, a complete overview of skin cancer, starting from the signaling pathways involved, newer developed drugs with their targets and limitations, along with the emerging role of natural products alone or in combination as potent anticancer agents and their molecular mechanism involved has been discussed. Apart from this, various nano-cargos have also been mentioned here, which can play a significant role in the management and treatment of different types of skin cancer.

Sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children: study protocol for a pragmatic randomised controlled trial.

BACKGROUND: Autism spectrum disorder (ASD) is a common lifelong condition affecting 1 in 100 people. ASD affects how a person relates to others and the world around them. Difficulty responding to sensory information (noise, touch, movement, taste, sight) is common, and might include feeling overwhelmed or distressed by loud or constant low-level noise (e.g. in the classroom). Affected children may also show little or no response to these sensory cues. These 'sensory processing difficulties' are associated with behaviour and socialisation problems, and affect education, relationships, and participation in daily life. Sensory integration therapy (SIT) is a face-to-face therapy or treatment provided by trained occupational therapists who use play-based sensory-motor activities and the just-right challenge to influence the way the child responds to sensation, reducing distress, and improving motor skills, adaptive responses, concentration, and interaction with others. With limited research into SIT, this protocol describes in detail how the intervention will be defined and evaluated. METHODS: This is a two-arm pragmatic individually 1:1 randomised controlled trial with an internal pilot of SIT versus usual care for primary school aged children (aged 4 to 11 years) with ASD and sensory processing difficulties; 216 children will be recruited from multiple sources. Therapy will be delivered in clinics meeting full fidelity criteria for manualised SIT over 26 weeks (face-to-face sessions: two per week for 10 weeks, two per month for 2 months; telephone call: one per month for 2 months). Follow-up assessments will be completed at 6 and 12 months post-randomisation. Prior to recruitment, therapists will be invited to participate in focus groups/interviews to explore what is delivered as usual care in trial regions; carers will be invited to complete an online survey to map out their experience of services. Following recruitment, carers will be given diaries to record their contact with services. Following intervention, carer and therapist interviews will be completed. DISCUSSION: Results of this trial will provide high-quality evidence on the clinical and cost effectiveness of SIT aimed at improving behavioural, functional, social, educational, and well-being outcomes for children and well-being outcomes for carers and families. TRIAL REGISTRATION: ISRCTN14716440 . Registered on 8 November 2016.

Curcumin-loaded lipid nanocarrier for improving bioavailability, stability and cytotoxicity against malignant glioma cells.

OBJECTIVE: In the present study, Curcumin (CU)-loaded nanocarrier (NC) such as nanoemulsion (NE) was developed with the objective of increasing its cytotoxicity and bioavailability through lymphatic transport by enhancing its solubility and intestinal permeability. MATERIALS AND METHODS: Based on the area obtained in pseudoternary phase diagram, various % combination of Labrafac Lipophile WL 1349, Solutol HS 15, Transcutol HP and distilled water were selected. Formulations which passed physical stability studies were selected for further studies such as globule size, zeta potential, in vitro release, ex vivo permeation, in vitro lipolysis studies, bioavailability studies and cytotoxicity against glioblastoma cells (U-87). RESULT AND DISCUSSION: The optimized NC (NE-SB1) had small average globule diameter of 67 ± 6 nm with zeta potential of -37 ± 2.5 mv which indicated long-term dispersion stability. During in vitro lipolysis study, the digestion rate of medium chain triglycerides increased with decreased globule diameter. Statistically significant difference was found in AUC0-inf of NC formulation (p < 0.05) compared to CU suspension. The relative bioavailability of NC was found 11.88 ± 0.47 with respect to CU suspension. During cytotoxicity studies, IC50 of CU solution on U87 cells was found 24.23 µM, while for the NE- SB1 it was 16.41 µM. The optimized formulation was found to be stable during 6 months of accelerated stability. CONCLUSION: The overall results revealed that the CU-loaded NC is a very effective approach for enhancing the oral absorption of poorly water-soluble drug CU and have great potential for future clinical application.

Engaging young people who misuse substances in treatment.

PURPOSE OF REVIEW: The focus of this review is to examine service utilization, treatment effectiveness, and future directions for adolescents who misuse substances. RECENT FINDINGS: Although the effectiveness of treatments has improved in the last two decades, young people's utilization of services has remained relatively stable. This is disconcerting because early intervention improves outcomes and deterioration is associated with physical, psychological, and social problems. The requirement for coordinated service provision across a wide range of treatment agencies cannot be emphasized enough, because young substance misusers come to services with a variety of symptoms and problems. It is encouraging that, to date, treatment studies indicate that adolescents in almost all types of treatment reduce their use of substances. The greatest reductions are shown for family therapy, followed by cognitive behavior therapy (CBT), motivational enhancement therapy (MET)/CBT, MET behavior therapy, and pharmacological treatment. Despite the developing treatment literature, important methodological limitations restrict comparability between studies. SUMMARY: The requirement for holistic, systematic assessments should include adolescents' social contexts, trauma, and psychiatric and physical illnesses because they are the cornerstones to understanding engagement and retention. Our review shows the importance of coordinating primary healthcare, mental health, and substance abuse treatment facilities, and highlights networking between other providers as integral to providing an optimal response to this unpredictable, often marginalized, group.

Effects of silymarin nanoemulsion against carbon tetrachloride-induced hepatic damage.

Silymarin is a complex mixture of four flavonolignan isomers (silybin, isosilybin, silydianin and silychristin) obtained from 'milk thistle' (Silybum marianum). This plant compound is used almost exclusively for hepatoprotection. Because of its low and poor oral bioavailability, silymarin was formulated as a nanoemulsion to increase its solubility (and so its oral bioavailability) as well as therapeutic activity. The present study assessed the hepatoprotective activity on Wistar rats by determining biochemical parameters and histopathological properties of the nanoemulsion formulation of silymarin against carbon tetrachloride (CCl(4))-induced hepatotoxicity. Hepatoprotective activity was evaluated by the activity of serum alkaline phosphatase, alanine transaminase and aspartate transaminase; antioxidative defence markers (concentration of reduced glutathione); oxidative stress parameter (thiobarbituric acid reactive substances) and liver histopathology. The nanoemulsion-treated group showed significant decreases in glutamate oxaloacetate transaminase, pyruvate transaminase, alkaline phosphotase, total bilirubin and tissue lipid peroxides and increased total protein, albumin, globulin and tissue glutathione as compared to toxicant. The results indicate an excellent potential of the nanoemulsion formulation for the reversal of CCl(4)-induced liver toxicity in rats as compared to standard silymarin.

Conundrum and therapeutic potential of curcumin in drug delivery.

Turmeric, the source of the polyphenolic active compound curcumin (diferuloylmethane), has been used extensively in traditional medicine since ancient times as a household remedy against various diseases, including hepatic disorders, cough, sinusitis, rheumatism, and biliary disorders. In the past few decades, a number of studies have been done on curcumin showing its potential role in treating inflammatory disorders, cardiovascular disease, cancer, AIDS, and neurological disorders. However, the main drawback associated with curcumin is its poor aqueous solubility and stability in gastrointestinal fluids, which leads to poor bioavailability. Multifarious novel drug-delivery approaches, including microemulsions, nanoemulsions, liposomes, solid lipid nanoparticles, microspheres, solid dispersion, polymeric nanoparticles, and self-microemulsifying drug-delivery systems have been used to enhance the bioavailability and tissue-targeting ability of curcumin. These attempts have revealed promising results for enhanced bioavailability and targeting to disease such as cancer, but more extensive research on tissue-targeting and stability-related issues is needed. Tissue targeting and enhanced bioavailability of curcumin using novel drug-delivery methods with minimum side effects will in the near future bring this promising natural product to the forefront of therapy for the treatment of human diseases such as cancer and cardiovascular ailments. We provide a detailed analysis of prominent research in the field of curcumin drug delivery with special emphasis on bioavailability-enhancement approaches and novel drug-delivery system approaches.

Chronopharmaceutics: a promising drug delivery finding of the last two decades.

Pulsatile drug delivery system capable of releasing the drug after a predetermined lag period in pulsed or controlled release manner recently has drawn the attention of both academic and industrial research. Depending on the effective therapeutic application of the drug, a variety of design strategies have been formulated in the pursuit of pulsatile release. Circadian (24 hr cycle) dependency of various physiological and pathological functions is well established, thus, it becomes imperative to develop a drug delivery system to achieve release of drug at specific site and time. Such systems are advantageous for drugs which have an extensive first pass metabolism, biological tolerance, needs targeting of locally absorbed / active drug to a specific site in intestine and are useful for the therapy for chronopharmacological needs. This manuscript portrays the important patents related to chronomodulated release system such as system with eroding, rupturing or soluble barrier coatings. In addition, recently developed chronotherapeutic dosage forms including tablets, capsules, pellets, beads implants, osmotic pump, liposome, thermoresponsive, inflammation stimuli sensitive, electrical stimuli sensitive, ultrasound stimuli responsive, magnetic stimuli responsive etc., are also conferred.

Distinctive features of "chronotherapeutic" and "pulsatile" drug delivery systems negating the practice of their interchangeable terminology.

The term pulsatile drug delivery has often been used as a synonym to chronotherapeutic drug delivery. This needs to be given a thought as both the drug delivery systems are entirely addressing different needs of the patients as well as the intentions of the formulators being different. Chronotherapeutic systems are based completely on circadian needs and response of the body and the need of the drug to be in its maximum concentrations at a particular time of the day, the fact being supported by endless list of ailments which elicit the related symptoms at a particular time of the day. Considering the formulation approach, one does not find major differences among site-specific chronotherapeutic systems and the basic and more conventional intestinal or colon targeted systems due to the mechanism and the site of landing of drug of both being almost similar even though the intention of the formulator being different. An ideal pulsatile system is the one delivering drug in different pulses with multiple troughs in release profile. The article explores the major differences in between the two systems and highlights the need of using appropriate terminology for these individual and distinct systems catering different needs.

Status of novel drug delivery technology for phytotherapeutics.

Herbal medicines have been widely used all over the world since ancient times and have been recognized by physicians and patients for their better therapeutic value as they have fewer adverse effects as compared with modern medicines. However, phytotherapeutics needs a scientific approach to deliver the components in a sustained manner to increase patient compliance and avoid repeated administration. This can be achieved by designing novel drug delivery systems for herbal constituents. Novel drug delivery systems not only reduce the repeated administration to overcome non-compliance, but also help to increase the therapeutic value by reducing toxicity and increasing the bioavailability, and so on. Recently, pharmaceutical scientists have shifted their focus to designing a drug delivery system for herbal medicines using a scientific approach. For a long time herbal medicines were not considered for development as novel formulations owing to lack of scientific justification and processing difficulties, such as standardization, extraction and identification of individual drug components in complex polyherbal systems. However, modern phytopharmaceutical research solves the scientific needs for herbal medicines as in modern medicine, which gives way for developing novel formulations such as nanoparticles, microemulsions, matrix systems, solid dispersions, liposomes, solid lipid nanoparticles, and so on. This article summarizes various drug delivery technologies for herbal actives, which are gaining more attention for better therapeutic response.

Multiple-pulse drug delivery systems: setting a new paradigm for infectious disease therapy.

BACKGROUND: Pulsatile drug delivery of actives based on the body's biological rhythms came into sight as a novel and emerging concept in the field of drug delivery. The concept of late has given birth to another field of research worth exploring: multiple-pulse drug delivery. OBJECTIVE: Delivering a drug in multiple pulses has been applied to antibiotics for effective and patient compliant drug delivery. Delivering antibiotics in divided pulses results in better annihilation of microbes, as it prevents them going into a resistant/dormant stage and developing biological tolerance. The concept appears to have potential, and on 16 March 2009 MiddleBrook Pharmaceuticals, Inc. will launch the first of such once-daily product based on their proprietary pulsatile drug delivery technology, PULSYS. METHODS: This review focuses on the rationale, possible strategies and technologies employed for multiple-pulse delivery, as well as current status and future trends. CONCLUSION: The concept is in its infancy and promises great potential in the fight against microbial resistance; many approved formulations based on similar approaches with new and improved therapeutic paradigms are anticipated in the near future.

Dental therapeutic systems.

The recognition of periodontal diseases as amenable to local antibiotherapy has resulted in a paradigmatic shift in treatment modalities of dental afflictions. Moreover the presence of antimicrobial resistance, surfacing of untoward reactions owing to systemic consumption of antibiotics has further advocated the use of local delivery of physiologically active substances into the periodontal pocket. While antimicrobials polymerized into acrylic strips, incorporated into biodegradable collagen and hollow permeable cellulose acetate fibers, multiparticulate systems, bio-absorbable dental materials, biodegradable gels/ointments, injectables, mucoadhesive microcapsules and nanospheres will be more amenable for direct placement into the periodontal pockets the lozenges, buccoadhesive tablets, discs or gels could be effectively used to mitigate the overall gingival inflammation. Whilst effecting controlled local delivery of a few milligram of an antibacterial agent within the gingival crevicular fluid for a longer period of time, maintaining therapeutic concentrations such delivery devices will circumvent all adverse effects to non- oral sites. Since the pioneering efforts of Goodson and Lindhe in 1989, delivery at gingival and subgingival sites has witnessed a considerable progress. The interest in locally active systems is evident from the patents being filed and granted. The present article shall dwell in reviewing the recent approaches being proffered in the field. Patents as by Shefer, et al. US patent, 6589562 dealing with multicomponent biodegradable bioadhesive controlled release system for oral care products, Lee, et al. 2001, US patent 6193994, encompassing a locally administrable, biodegradable and sustained-release pharmaceutical composition for periodontitis and process for preparation thereof and method of treating periodontal disease as suggested by Basara in 2004via US patent 6830757, shall be the types of intellectual property reviewed and presented in the current manuscript.

Design, development and evaluation of novel nanoemulsion formulations for transdermal potential of celecoxib.

The aim of the present study was to investigate the potential of nanoemulsion formulations for transdermal delivery of celecoxib (CXB). The in vitro skin permeation profile of optimized formulations was compared with CXB gel and nanoemulsion gel. Significant increase in the steady state flux (Jss), permeability coefficient (Kp) and enhancement ratio (Er) was observed in nanoemulsion formulations T1 and T2 (p < 0.05). The highest value of these permeability parameters was obtained in formulation T2, which consisted of 2% (m/m) of CXB, 10% (m/m) of oil phase (Sefsol 218 and Triacetin), 50% (m/m) of surfactant mixture (Tween-80 and Transcutol-P) and 40% (m/m) water. The anti-inflammatory effects of formulation T2 showed a significant increase (p < 0.05) in inhibition after 24 h compared to CXB gel and nanoemulsion gel on carrageenan-induced paw edema in rats. These results suggested that nanoemulsions are potential vehicles for improved transdermal delivery of CXB.

A validated HPTLC method for determination of tea tree oil from cosmeceutical formulations.

A HPTLC method has been developed and validated for the determination of tea tree oil from cosmeceutical formulations. Tea tree oil concentration was estimated by analyzing the terpinen-4-ol content. The method employed TLC aluminium plates precoated with silica gel 60F-254. The solvent system consisted of toluene and ethyl acetate in the ratio 85:15. The calibration curve of terpinen-4-ol was linear in the range of 100-900 ng. The polynomial regression data for the calibration plots showed a good linear relationship with r(2)=0.9949. The Rf value of terpinen-4-ol was found to be 0.62+/-0.05. The method was validated for precision and accuracy. The minimum detectable amount was found to be 60 ng. The limit of quantitation was found to be 100 ng. The drug content was within the limits (+/-5% of the labeled content of the formulations). The recovery of tea tree oil was greater than 99%. The method was found to be simple, sensitive, precise, accurate and specific for estimation of tea tree oil from formulations.

Tea tree oil concentration in follicular casts after topical delivery: determination by high-performance thin layer chromatography using a perfused bovine udder model.

Tea tree oil, a popular antimicrobial agent is recommended for the treatment of acne vulgaris, a disease of the pilosebaceous unit. Tea tree oil formulations (colloidal bed, microemulsion, multiple emulsion, and liposomal dispersion containing 5% w/w tea tree oil) were applied to bovine udder skin. The follicular uptake of tea tree oil upon application was determined by a cyanoacrylate method. Tea tree oil was determined by quantifying terpinen-4-ol content using high-performance thin layer chromatography. The accumulation of tea tree oil in the follicular casts was 0.43 +/- 0.01, 0.41 +/- 0.009, 0.21 +/- 0.006, and 0.16 +/- 0.005 percentage by weight (milligram oil/gram of sebum plug) for microemulsion, liposomal dispersion, multiple emulsion, and colloidal bed, respectively. This is the first study of its kind to quantify tea tree oil concentration in the follicles.