Development and Investigation of Vitamin C-Enriched Adapalene-Loaded Transfersome Gel: a Collegial Approach for the Treatment of Acne Vulgaris.

Adapalene-loaded transfersome gel containing vitamin C as a combination therapy for the management of acne vulgaris was developed in the present study. The transfersome was prepared by reverse-phase evaporation, and the effect of various process parameters were investigated by the Design of Experiment (DOE) approach and optimized based on the particle size (PS), polydispersity index (PDI), zeta potential (ZP), and entrapment efficiency (EE). The selected tranfersomes were further evaluated for their thermal behavior and morphology by transmission electron microscopy and turbidity measurements and incorporated into a gel with/without vitamin C. The gel was evaluated and compared with the marketed product (Adiff gel) for various physicochemical parameters, and in vivo studies in testosterone-induced rat models of acne. The prepared transfersomes had PS in the range of 280 to 400 nm, PDI values of 0.416 to 0.8, ZP of - 38 to - 20 mV, and % EE of 32 to 70%. DSC studies confirmed a positive interaction of the components in the transfersome. Surface morphology confirmed that the vesicles were spherical, unilamellar, and discrete. A relative deformability study showed higher elasticity of the transfersomes compared with Adiff aqs gel. Ascorbyl-6-palmitate in adapalene-loaded transfersome gel containing vitamin C (ADVTG) was found to have a good antioxidant free radical-scavenging activity. An in vitro drug release study showed that the sustained release of the transfersomal formulations was attributed to the flexibility of the vesicles by which penetration was increased. ADVTG was found to be promising in treating acne compared with the marketed product. Graphical Abstract.

Neurocognitive profile of patients with Bipolar Affective Disorder in the euthymic phase.

Bipolar disorder is a chronic psychiatric condition characterized by episodes of elevated/irritable and depressed moods resulting in the loss of more disability-adjusted life years (DALYs) than other major conditions. The neurocognitive impairments in these patients interfere with sustained goal-directed performance and achievement even during the euthymic phase of the illness. METHODOLOGY: The study aimed to explore the neurocognitive profile of patients in their euthymic phase. We matched 30 patients diagnosed with Bipolar Affective Disorder (BD) in the age range of 20-40 years with 30 healthy controls (with no axis I or II diagnosis, assessed on MINI) matched on age, gender, and education. The neurocognitive profile was assessed using NIMHANS Neuropsychology Battery. RESULTS: Euthymic phase patients with bipolar disorder had statistically significant low scores on the speed of processing information as compared to healthy controls. Although impaired in BD group, no statistically significant difference was found between the two groups on executive functions and memory. CONCLUSION: The findings of the study suggest that cognitive retraining aimed at ameliorating these deficits can be a used as an essential intervention in rehabilitation programs to successfully reintegrate patients with the bipolar affective disorder into the society. The research also indicates that despite the symptomatic recovery between the episodes, impairments in the speed of processing information continue to disrupt performance in patients with Bipolar Disorder.

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada.

Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product. However, such prescriptions are carried out in a controlled manner. Prior to being approved, the medicinal product will have been evaluated in a population pool containing fewer than 5,000 patients and in a predesigned environment where several factors may be lacking, such as the absence of women of childbearing potential, geriatric patients and paediatric patients. Therefore, it is not surprising that several major adverse drug reactions are detected only when the product has been prescribed to the general population. National and international regulatory bodies have devised systems for monitoring medicinal products after marketing, commonly known as postmarketing surveillance systems. Postmarketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. The primary purpose for conducting postmarketing surveillance is to identify previously unrecognized adverse effects as well as positive effects. The Yellow Card scheme, practiced in the United Kingdom and the Canada Vigilance Program adopted in the Canadian jurisdiction, are two of the most successful postmarketing surveillance systems implemented across the world. Therefore, this article intends to discuss postmarketing surveillance and its role in the context of the United Kingdom and Canadian jurisdictions with a view on presenting key aspects and measures that are employed for operating an efficient postmarketing surveillance system in regulated markets.

Fixed-dose combinations banned in India: is it the right decision? An eye-opening review.

Introduction: Fixed-dose combination (FDC) medicines contain more than one approved active pharmaceutical ingredient (API), are manufactured as a fixed-dose and packed in a single dosage form. FDCs have been drawing attention from the pharmaceutical industries because of the government's ban on 328 irrational FDCs in September 2018. The Drug Technical Advisory Board (DTAB) recommended that 'there is no therapeutic justification' for the active ingredients in the banned FDCs and accordingly these combinations 'may involve a risk to human beings'. Areas covered: The review illustrates the present status of FDCs, its regulatory framework, approvals in India and discusses the substantive cause behind the ban on FDCs in India. Expert opinion: The expert stress to establish a robust regulatory system for the approval of FDCs in India. The pharmaceutical industries should not perceive the ban against irrational FDCs as an impediment; rather, they should view as an opportunity to establish a stronger healthcare system. The current review is an eye-opener for the section of people who consider that the ban on FDCs is irrational. However, the ban on 328 FDCs may prove a landmark decision for the development of stronger healthcare policy in India.