Search

Background: Healthcare costs are a major burden on the society of developing countries like India. Countries like India try to limit healthcare costs in support of generic medicine. So, the Indian government initiated the Jan Aushadhi scheme in 2008 to provide high-quality generic medication at a low cost. Aim: The aim of the study was to compare the cost difference between Jan Aushadhi generic pharmaceutical formulations and branded medications in Tamil Nadu. Settings and Design: Pharmaco economic - Cost minimization observational study. Methods and Material: Study Duration: Five months, from February 2023 to June 2023. Study Place: 10 Jan Aushadhi outlets from various districts of Tamil Nadu. Sampling technique: Convenience sampling technique Statistical analysis used: Mean median, mode and Percentage. Results: A total of 729 medications were available in 10 Jan Aushadhi outlets. The Jan Aushadhi outlet has the most cardiovascular medications and the fewest antimalarial medications among different categories of drugs. Erythropoietin has the biggest cost difference between the average cost of branded medications and Jan Aushadhi drug costs, while Digoxin has the lowest cost difference. Antitubercular drugs, Oxytocics, Antileprosy drugs, Antiparkinsonism categories of drugs also delisted in Jan Aushadhi outlet. Conclusions: Compared to branded drugs, Jan Aushadhi's generic drugs are 64.65 % less costly on an average as observed in our study. The manufacturer of Jan Aushadhi shops is a WHO and GMO-certified company, and they manufacture branded drugs. So, there will be no quality compromise in Jan Aushadhi's generic drugs. [ABSTRACT FROM AUTHOR]

The fruit of Piper longum L. (PL) is widely utilized in China for medicinal and dietary purposes, and it is also used in Ayurvedic medicine in India to treat gastric disorders and other ailments. In the present study, a strategy combining serum pharmacochemistry with network pharmacology was proposed to screen the bioactive metabolites derived from PL and explore their potential functional mechanisms. The strategy primarily involved investigating the anti-gastric ulcer activities, network pharmacology analysis, and metabolite identification. The results demonstrated the efficacy of PL in protecting against ethanol-induced gastric ulcers. Through network pharmacology approaches, potential drug-disease common targets were identified. GO enrichment analysis predicted that PL might influence multiple biological processes, such as lipid metabolism and inflammatory response. KEGG enrichment analysis suggested the involvement of the TNF and AGE-RAGE signaling pathways. Molecular docking further indicated that the synergistic effect of sesamin, pipeline, and other ingredients could be the main contributors to PL's anti-inflammatory and antibacterial activities. Additionally, the serum pharmacochemistry of PL was established, enabling the screening of absorbed components and metabolites for their anti-gastric ulcer activity. A total of 23 prototypes and 17 metabolites were found to significantly contribute to the anti-gastric ulcer activity, suggesting that these bioactive compounds could serve as potential active components of PL. Overall, this investigation provided an experimental foundation to support the clinical application of PL in gastric ulcer therapy. [ABSTRACT FROM AUTHOR]

The use of mouthwash in India is underrated and lacks an expert consensus for optimum clinical use and benefits. Ten expert dentists and one expert otolaryngologist participated in a panel discussion where insights were sought to understand the role of mouthwash in maintaining oral hygiene and preventing/treating dental diseases and their complications. Current evidence regarding the effectiveness of octenidine-based mouthwash was also explored. Consensus was formulated on the basis of expert insights and contemporary supportive evidence. Antimicrobial mouthwash was recommended as an adjunct to brushing as it helps control plaque and reduce gingivitis, thereby maintaining oral hygiene in routine and preand post-dental procedures. The risk of alveolar osteitis and bacteremia following tooth extraction and the incidence or severity of oral mucositis in patients treated with chemotherapy or radiotherapy may also be reduced with the use of mouthwash. Mouthwash use also reduces the risk of fungal infections, including denture stomatitis, and helps treat halitosis. Antimicrobials such as chlorhexidine, octenidine,cetylpyridinium chloride, probiotics or essential oils, and some antifungal and anti-inflammatory agents are recommended as active agents in mouthwash. The suggested duration of mouthwash use may be 2 weeks to 6 months depending upon the clinical condition. Octenidine-based mouthwash could be an effective alternative to other currently available mouthwash formulations. Appropriate use of mouthwash in addition to mechanical means of plaque control shall provide significant adjunctive benefits in specific clinical situations and for general oral health. [ABSTRACT FROM AUTHOR]

Objective: To assess the bioequivalence of 10 mg dapagliflozin tablets compared with that of 10 mg Farxiga® (dapagliflozin) tablets of AstraZeneca Pharmaceuticals LP, USA in healthy, adult volunteers under fasting conditions. Materials and Methods: This was an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, oral bioequivalence study. Volunteers were randomized to receive either test product or reference product of 10 mg dapagliflozin tablets under the fasting condition with a nine-day washout period. The primary pharmacokinetic (PK) parameters were maximum plasma concentration (Cmax), area under the curve (AUC) at time t (AUCt), and AUC extrapolated to infinity (AUCinf). Adverse events were assessed as safety endpoints. The bioequivalence was assessed to evaluate that the two formulations are not different from one another if the 90% confidence interval for the ratio of the geometric least square means falls completely within the predefined range of 80-125%. Results: Fifty-two healthy adult volunteers were randomized, and 47 completed the study. The mean values for Cmax, AUCt, and AUCinf were almost identical for test and reference products after administration to healthy human volunteers under fasting conditions. A total of 14 adverse events were reported by 10 volunteers during the study. All adverse events were mild to moderate in nature and did not cause study withdrawal. Conclusion: The test product dapagliflozin 10 mg was bioequivalent with the reference product in healthy, adult, human volunteers under fasting conditions. The availability of the affordable generic dapagliflozin has the potential to improve clinical outcomes in millions of patients in India because of its renoprotective, cardioprotective, and glucoselowering effects. [ABSTRACT FROM AUTHOR]

Background Dispersible pediatric fixed-dose combination (FDC) tablets delivering higher doses of first-line antituberculosis drugs in World Health Organization–recommended weight bands were introduced in 2015. We report the first pharmacokinetic data for these FDC tablets in Zambian and South African children in the treatment-shortening SHINE trial. Methods Children weighing 4.0–7.9, 8.0–11.9, 12.0–15.9, or 16.0–24.9 kg received 1, 2, 3, or 4 tablets daily, respectively (rifampicin/isoniazid/pyrazinamide [75/50/150 mg], with or without 100 mg ethambutol, or rifampicin/isoniazid [75/50 mg]). Children 25.0–36.9 kg received doses recommended for adults <37 kg (300, 150, 800, and 550 mg/d, respectively, for rifampicin, isoniazid, pyrazinamide, and ethambutol). Pharmacokinetics were evaluated after at least 2 weeks of treatment. Results In the 77 children evaluated, the median age (interquartile range) was 3.7 (1.4–6.6) years; 40 (52%) were male and 20 (26%) were human immunodeficiency virus positive. The median area under the concentration-time curve from 0 to 24 hours for rifampicin, isoniazid, pyrazinamide, and ethambutol was 32.5 (interquartile range, 20.1–45.1), 16.7 (9.2–25.9), 317 (263–399), and 9.5 (7.5–11.5) mg⋅h/L, respectively, and lower in children than in adults for rifampicin in the 4.0–7.9-, 8–11.9-, and ≥25-kg weight bands, isoniazid in the 4.0–7.9-kg and ≥25-kg weight bands, and ethambutol in all 5 weight bands. Pyrazinamide exposures were similar to those in adults. Conclusions Recommended weight band–based FDC doses result in lower drug exposures in children in lower weight bands and in those ≥25 kg (receiving adult doses). Further adjustments to current doses are needed to match current target exposures in adults. The use of ethambutol at the current World Health Organization–recommended doses requires further evaluation. [ABSTRACT FROM AUTHOR]

A major hurdle in pediatric formulation development is the lack of safety and toxicity data on some of the commonly used excipients. While the maximum oral safe dose for several kinds of excipients is known in the adult population, the doses in pediatric patients, including preterm neonates, are not established yet due to the lack of evidence-based data. This paper consists of four parts: (1) country-specific perspectives in different parts of the world (current state, challenges in excipients, and ongoing efforts) for ensuring the use of safe excipients, (2) comparing and contrasting the country-specific perspectives, (3) past and ongoing collaborative efforts, and (4) future perspectives on excipients for pediatric formulation. The regulatory process for pharmaceutical excipients has been developed. However, there are gaps between each region where a lack of information and an insufficient regulation process was found. Ongoing efforts include raising issues on excipient exposure, building a region-specific database, and improving excipient regulation; however, there is a lack of evidence-based information on safety for the pediatric population. More progress on clear safety limits, quantitative information on excipients of concern in the pediatric population, and international harmonization of excipients' regulatory processes for the pediatric population are required. [ABSTRACT FROM AUTHOR]

Objective: Ocuserts are sterile, solid, or semisolid dosage forms prepared to attain increased contact time between the drug and the conjunctival tissue to keep up a constant release of drug when placed in the lower cul-de-sac or conjunctival sac of the eye. The aim of formulating this delivery system was to treat both inflammatory and infectious conditions of the eye with increased ocular residence time by releasing drugs at a slow and constant rate. Method: Gatifloxacin, and prednisolone ocuserts were prepared by solvent casting method, and evaluated for physical appearance, uniformity of weight, thickness, folding endurance, drug content, surface pH, in-vitro, and ex-vivo release profile. Results: All formulated inserts exhibited positive results in terms of their evaluation parameters. Ocuserts were sterile, with no turbidity in selected media during the study, and they were stable throughout six months. Conclusion: Results suggested that prepared optimized ocusert formulation would be a suitable alternative to eye drops for treating conjunctivitis and other bacterial infections. [ABSTRACT FROM AUTHOR]

Ghee is widely considered as the Indian name for clarified butterfat and processing of ghee with therapeutic herbs i.e., ghrita is renowned for augmenting their medicinal properties. The wound is considered as a challenging clinical problem with early and late complications. To reduce the burden of wounds with the shortest period and minimum scaring, an attempt was made to prepare and evaluate the wound healing potential of ghee based polyherbal formulation. Based on local ethnic tribal claims, Semecarpus anacardium L., Argemone mexicana L., Cocculus hirsutus L., and Woodfordia fruticosa K. were collected from Western Ghats of India. The polyherbal Bhallatakadi Ghrita (BG) formulation was prepared as per Ayurvedic procedure and assessed for its wound healing potential using incision and excision wound animal models. BG treated group showed a complete contraction of wounds (99.82 ± 0.10%) (p<0.001) with 15.17 ± 0.40 days re-epithelization time and breaking strength (531.50 ± 5.89) (p<0.05). The hydroxyproline content of BG was found to be significantly higher i.e., 4.23 ± 0.21 (p<0.05). Quantitative estimation of BG exhibited 54.7 ± 3.7 mg100 g−1 of polyphenols and 42.3 ± 5.4 mg.100 g−1 flavonoids in terms of gallic acid and quercetin respectively. HPLC analysis revealed the presence of gallic acid and quercetin whereas the presence of fatty acids was confirmed by GC-MS analysis. It may conclude that the presence of quercetin, gallic acid, and fatty acids could have accelerated the healing rate of the ghrita formulation, as they have already been known for their potential wound healing properties. [ABSTRACT FROM AUTHOR]

In this Minireview, the importance and implementation of green chemistry practices in the pharmaceutical industry are illustrated. With notable examples, some of the most important industrial organic transformations are discussed along with their applications in the synthesis of drug molecules. A brief comparison between traditional unsustainable methods and modern green methods is made to shed light on the economic and environmental benefits of greener methods. Finally, green chemistry practices in the pharmaceutical industries of India and China are also discussed. [ABSTRACT FROM AUTHOR]

Background: Combination of curcumin with anti-inflammatory drug like caffeine shows augmented antipsoriatic action compared to curcumin alone and reduce the time taken for treatment of Psoriasis. Objective: The objective of the present study was to develop nanosponge (NS) based topical gel of curcumin (CUR) and caffeine (CFN) combination that acts as a potential system for the treatment of psoriasis. Methods: NS composed of dimethyl carbonate (DMC) as crosslinker and beta-cyclodextrin (β-CD) as polymer were prepared by hot melt method and incorporated in topical gels. Factorial design (32) was constructed in a fully randomized manner to study all nine possible experimental runs. The gels were prepared by varying the content of carbopol-934 (gelling agent) (X1) and guar gum (polymer) (X2). The effect of these two independent variables on viscosity (Y1) and in vitro percent drug release (Y2) of prepared gels was evaluated. Other evaluation studies for NS and nanogels were conducted. In vivo animal studies were carried out for optimized formulation using mouse model of imiquimod-induced psoriasis. Results: The physical and chemical characteristics exhibited by the prepared NS and gels (F1-F9) were found to be optimal. The optimization resulted in achieving formulation N10 with 69.72% in vitro drug release and 12,329.78cp viscosity. Histopathology studies revealed that prepared nanogel has promising anti-psoriatic activity. The results concluded that CUR and CFN combination has reduced the time required for showing anti-psoriatic activity to 10 days when compared to CUR alone that took around 20 days. Moreover, the nanogel has depicted sustained drug release till 12 h. Conclusions: From the experimental findings it has been concluded that CUR and CFN combination significantly augmented the anti-psoriatic efficacy with respect to individual components and also reduced the time required for onset of effect. Thus, the proposed nanogel would be an imperative drug delivery system for more effective anti-psoriatic therapy. [ABSTRACT FROM AUTHOR]

The present study throws light on the scholarly communication of three leading countries in the field of pharmaceutical research as reflected in SCOPUS database during 1998-2017. In terms of publication output, United States with two leading Asian countries, China and India leads with 40.54 per cent share of the global research publication share in pharmaceutical sciences. The global outcome of scholarly communication in the field of pharmaceutical research is 1395221. The study mainly focuses both on qualitative and quantitative research growth of United States, China and India in terms of output of scholarly communication, citation impact, relative research effort, common sources used for publications and research collaboration. The growth pattern of three leading countries is highly chaotic. The relative research effort of India and China increased during 2008-2017 while in United States, it was decreased. Bioorganic and Medicinal Chemistry, Tetrahedron Letters and Tetrahedron are the common source of communication in these three countries. All the three countries show the positive shift in international collaboration during 1998-2002 to 2012-2017 in pharmaceutical research. [ABSTRACT FROM AUTHOR]

The relationship between the ethical standards for the governance of clinical trials and market forces can be complex and problematic. This article uses India as a case study to explore this nexus. From the mid-2000s, India became a popular destination for foreign-sponsored clinical trials. The Indian government had sought to both attract clinical trials and ensure these would be run in line with internationally accepted ethical norms. Reports of controversial medical research, however, triggered debate about the robustness and suitability of India's regulatory system. In response to civil society pressure and interventions by the Supreme Court, the Indian government proposed additional measures aimed at strengthening protections for clinical trial participants. Whilst the reforms can be seen as a victory for human rights activists, they have also been criticised as being overly burdensome for sponsors. Indeed, their announcement prompted an exodus of clinical trials from India. Fearful of losing business to 'rival' countries, the Indian government is revisiting some of its proposals. The Indian example suggests that research ethics frameworks and national policies for economic development are increasingly intertwined. Host countries are in theory free to improve the lot of research participants, but doing so may make them appear less attractive to foreign sponsors, who can simply shift their activities to more industry-friendly jurisdictions. Although these economic pressures are unlikely to lead to a regulatory 'race to the bottom', they may limit host countries' ability to enact socially desirable reforms. [ABSTRACT FROM AUTHOR]

The advocates of intellectual property rights project strong patent regime as an effective way to promote research and development (R&D) activities leading to innovation while others argue that they may adversely affect local industries in developing countries and result in monopoly pricing that may compromise on larger interests including public healthcare. The process patent regime has enabled Indian pharmaceutical firms to strengthen their technological capability and performance in domestic and global markets. As the country reintroduced product patent protection in 2005, Indian ‘copycats’ could not follow their reverse engineering technology anymore. Being a developing country and ‘pharmacy of the Global South’, India’s experience offers global dimensions to these debates. This article makes an attempt to reflect on India’s experience with the new patent regime; it looks into the pattern of R&D, trade and trend of product patenting in the pharmaceutical sector and revisits public health concerns. [ABSTRACT FROM AUTHOR]

Plants have been used by people to fulfil their spiritual, cultural, emotional and materialistic needs. In quest of using plants, man has forgotten the implications of overexploitation of these resources. Hence the question of restoring the balance has long been intriguing the conservation biologists. In this review we focus on the struggle of medicinal plants in the Eastern Ghats (EGs) of Andhra Pradesh (AP) in the changing scenario of overexploitation and destruction of natural habitats. Here we concentrate on a sum total of 267 medicinal plant taxa from these regions with due emphasis on their utility as leading herbal medicines. Endemic flora and the threat status of medicinal plants from this area are highlighted in this paper. Andhra Pradesh, so far. has been successful in having one biosphere reserve, six national parks and twenty one wildlife sanctuaries with over 13.000 sq km of forest cover, but there have been no proper scientific studies undertaken till date to evaluate the working and maintenance of these protected areas. As EGs of AP have received less attention from the Government and NGOs. the analysis of past research reports in this review gives a dariant call for a much awaited coordinated effort for conservation and management of plants in these areas. Furthermore, we stress on having a formal system to monitor the local pockets of these hilly ranges for a better coordinated conservation mechanism. This review is a humble attempt to give a wakeup call to all the policy makers, managers and other government officials working with protected areas and forest departments. The diversity of medicinal flora, uses and conservation priorities of Eastern Ghats of Andhra Pradesh form the subject matter for this review. [ABSTRACT FROM AUTHOR]

Ethnopharmacological relevance The Ayurvedic Pharmacopoeia of India (API) is a unique book of standards describing the quality, purity and strength of selected drugs that are manufactured, distributed, and sold by the licensed manufacturers in pan India. It is developed in two parts; the part one comprises of mono-monographs of medicinal substances of natural origin and part two includes selected compound formulations sourced from the schedule – I books under the Drugs and Cosmetics Act, 1940 comprising of popular Ayurvedic classics of different period of times. The first part of the Ayurvedic Formulary of India was published in 1978 and thereafter, the Ayurvedic Pharmacopoeia of India (mono-monograph) Part-I, Vol. I was published in the year 1989 and subsequently, the other volumes were published with their legalized status under Drugs and Cosmetics Act, 1940. Aim of the study The study was aimed to bring out the existing knowledge on the Ayurvedic pharmacopoeia with its chronological development reviewed from the ancient Vedic Compendia with its continuum in Ayurvedic classics of different period of time till recent past. Materials and methods A literary search based on the ancient origin of Ayurveda was carried out. The drug making from the natural resources and utility of the knowledge exist in classical Ayurvedic works of different period of time till composition of the Ayurvedic Pharmacopoeia of India and its importance as official documents of Govt. of India for Standards of Ayurvedic Drugs and its perspectives have been discussed. Results The present paper reviews on the systemic development and different aspects of drug-making (Pharmacopoeia) with evidence lying in the 5000 years old work of India. During the systematic review of the various works of different period of times (ancient, medieval and modern), it was found that the Ayurvedic Pharmacopoeia of India has its development during 20th Century as an official document of Govt. of India comprising of single drugs monograph and compound formulations. Conclusion In India, the development of the Indian Pharmacopoeia started in 20th Century on the recommendation of the Col. R.N. Chopra Committee and in 1978 the first part of the Ayurvedic formulary of India was published. Subsequently, the amendment in the drugs and cosmetics Act 1940 was brought in 1964 for regulation of the drugs in Indian Systems of Medicine (Ayurveda, Unani and Siddha). Later on the Ayurvedic Pharmacopoeia of India (Mono-Monograph) Part-I, Volume I, was published in the year 1989 and the other volumes were published subsequently in different years. [ABSTRACT FROM AUTHOR]

Objective: Treatment of contaminated wounds represents a significant challenge in healthcare and there is a need to develop approaches maximising skin retention to maintain therapeutic concentrations of anti-infectives at the wound site. The objective of the present study was to develop and evaluate mupirocin calcium nanolipid emulgels to enhance wound healing performance and patient acceptability. Methods: Nanostructured lipid carriers (NLCs) of mupirocin calcium were prepared by the phase inversion temperature method using Precirol ATO 5 (Gattefosse, India) and oleic acid as lipids and Kolliphor RH 40 (BASF, India) as surfactant and further incorporated into a gel base for topical delivery. Results: The particle size, polydispersity index and zeta potential of mupirocin NLCs were found to be 128.8±1.25nm, 0.283±0.003 and –24.2±0.56mV, respectively. In vitro release studies from developed emulgel showed sustained drug release over 24 hours. Ex vivo drug permeation studies through excised rat abdominal skin showed better skin permeation (1712.38±15. 57μg/cm2) from developed emulgel compared to marketed ointment (827.92±21.42μg/cm2) after 8 hours, which was in agreement with in vitro antibacterial activity. Studies on Wistar rats indicated the nonirritant potential of developed emulgels. Further, mupirocin emulgels showed improved efficacy in percent wound contraction of acute contaminated open wounds in Wistar rats using a full-thickness excision wound healing model. Conclusion: The emulgels of mupirocin calcium NLCs appear to be effective in the treatment of contaminated wounds due to increased skin deposition and sustained release, thereby enhancing the wound healing potential of existing molecules. [ABSTRACT FROM AUTHOR]

Ethnopharmacological relevance ‘Ubtan’ is a traditional herbal formulation in the Indian system of medicine being used in India and its subcontinent for a long time. Several commercial skin care formulations are marketed throughout this region as the name of Ubtan. Therefore, it is worthwhile to evaluate Ubtan in respect of its efficacy as skin care formulation. Aim of the study The present study was designed for the preparation of Ubtan and standardization through the chromatographic techniques by using suitable phyto-markers. Further, its antioxidant, sun protection factor (SPF) and anti-tyrosinase potential have been explored. Materials and methods Four in-house formulations (UF-1, UF-2, UF-3 and UF-4) were prepared by mixing a varied quantity of each powdered plants, i.e. turmeric ( Curcuma longa L.), Chickpea ( Cicer arietinum L.) and sandalwood ( Santalum album L.). Optimization of the formulations was made by evaluating its biological activity through in vitro assay. Evaluation of physicochemical properties of the optimized formulation (UF-1) has been carried out by analysis of pH, flow properties and stability. Moreover, RP-HPLC (reverse phase - high performance liquid chromatography) and HPTLC (high performance thin layer chromatography) standardization of UF-1 was performed for its quantitative and qualitative analysis. Results Ubtan formulations (UF-1to UF-4) showed free radical scavenging and ferric reducing potential. It may be due to its high phenolic and flavonoid content. Statistically, significant Pearson's correlation (r) was confirmed the positive correlation between phenolic content and SPF of the formulations. The tyrosinase inhibition study indicated that the formulations showed both diphenolase and monophenolase inhibitory activity. Among four formulations, UF-1 showed notable biological activity ( p <0.05). The content of curcumin and ascorbic acid was found to be 1.6% and 2.1% w/w respectively in UF-1 through RP-HPLC estimation. Physiochemical properties of the UF-1 exhibited good flow rate and aqueous solubility. From the stability studies, it can be anti cipated that the UF-1 was stable at 40 °C for longer periods. Microbial load count and heavy metal content (lead-Pb, arsenic-As, mercury-Hg and cadmium-Cd) of the formulation was also within the permissible limit of a pharmacopeial standard. Conclusion This scientific exploration helps to set the quality and safety standard of traditional cosmetic formulation, Ubtan and its further use as an herbal skin care product. [ABSTRACT FROM AUTHOR]

The article evaluates the essential oil yield and total citral content of nine cultivars of Cymbopogon or lemon grass. Analysis showed that the variety identified as OD-19 contained the highest amount of citral but had less amount of oil, while NLG-84, LS-1, Pragati, CKP-25 and LS-2 had similar amounts of citral. Results also showed that oil contents for CKP-25 and LS-2 were the highest.

Pityriasis Versicolor (PV) is a commonly encountered infection of the skin caused by Malassezia species. Despite effective conventional antifungal drugs, the prevention and treatment of PV remain a challenge. The Unani pharmacopoeial preparations Itrifal Hakim Ali (IHA) and Habb-e-Kalaf (HK) have been used in the treatment of PV for a long time. The Unani practitioners recommend these formulations for the successful treatment of PV in clinical practice. This study aimed to evaluate the efficacy and safety of Unani formulations IHA (oral) and HK (topical) in the treatment of PV. A single centre, randomized, active-controlled, parallel-group and open-label clinical study was carried out in the outpatient departments of the National Research Institute of Unani Medicine for Skin Disorders, Hyderabad, India. The participants diagnosed with PV of any gender aged between 18 and 60 years were randomized into the test group (n = 37) to receive oral IHA (10g/day) and topical HK and the active control group (n = 35) to receive oral Itraconazole (100 mg/day) and local Terbinafine (1%) for the period of 6 weeks. Of them, 30 participants in each group completed the duration of the protocol therapy. The outcome of this study was based on a per-protocol analysis of the data. The efficacy of the interventions was measured by post-treatment change in subjective clinical symptoms/signs, mean TSSS, IGA score, direct microscopy of fungal elements and DLQI. The dermal safety was assessed by Berger/Bowman Scoring Scale and systemic safety was evaluated by Urinalysis, haematological and biochemical parameters. This study observed statistically and clinically significant post-treatment reduction in itching (test group vs. active control group; 73.4% vs. 89.1%), hypopigmentation (63.2% vs. 57.1%), hyperpigmentation (60% vs. 65.5%), and scaling (91.6% vs. 92.7%) (p < 0.001). The differences in mean TSSS (5.4 ± 0.63 vs. 5.60 ± 0.32), IGA score (2.07 ± 0.15 vs. 1.74 ± 0.08) and DLQI (9.6 ± 2.06 vs. 9.04 ± 2.7) were also found clinically and statistically significant (p < 0.001) in each group when compared baseline data to post-treatment. On inter-group comparison, the changes in mean TSSS and DLQI were not found statistically significant at p < 0.05. But, the change in the mean IGA score was significant (p = 0.03). Further, the mycological cure was observed in 100% and 76.7% of participants in the test group and the control group respectively. On comparing inter-group the effects of the interventions on direct microscopy were found statistically significant (p = 0.034). In addition, no significant change in urinalysis, biochemical and haematological parameters from baseline to post-treatment in each group was observed. This study concluded that the test drugs (IHA and HK) were safe and effective in the treatment of PV. The oral (IHA) and local (HK) Unani formulations were tolerated well by all the participants The efficacy and safety of the IHA and HK were comparable to the standard drugs (Itraconazole and Terbinafine). [Display omitted] • Itrifal Hakim Ali (IHA) and Habb-e-Kalaf (HK) are used in the treatment of PV. • Clinical validation of treatment effect of IHA and HK was aimed in this study. • The improvement in TSS score, IGA score and DLQI was found clinically significant. • Issues of non-adherence and dermal safety of IHA and HK were negligible. • The safety and efficacy of IHA and HK were comparable to the standard drugs. [ABSTRACT FROM AUTHOR]

Phyllanthus reticulatus (Euphorbiaceae) is a medicinal plant that has been used in Zhuang medicine since ancient times. Traditionally, it has the effect of removing toxins and detumescence and can be used to treat hepatitis in China and India. Our previous studies have proved that the ethyl acetate extract of its leaves (PRPE) has an anti-hepatoma effect. To predict targets of an ethyl acetate extract of Phyllanthus reticulatus leaves (PRPE) in hepatoma treatment via network pharmacology and verify the predictions in a mouse model of liver cancer. Chemical constituents and therapeutic targets of P. reticulatus (PRP) were searched and predicted via public databases. A protein-protein interaction network comprising common targets was constructed, and the key gene targets were identified. Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) analyses were used for biological function and pathway enrichment analyses. The effects of PRP on BEL-7404 and HepG 2 cells were determined by MTT assay, apoptosis was measured by flow cytometry and hoechst44432/PI. And a nude mouse xenograft model was established to verify the anti-tumour effect in vivo. The histopathology of tumours was observed by staining with haematoxylin and eosin (H&E). Reverse transcription-polymerase chain reaction (RT-PCR) and immunohistochemistry were used to determine the gene and protein expression levels of phosphoinositide 3-kinase (PI3K), Akt1, p53, caspase-3, Bcl-2 and Bax, respectively. Twenty-seven chemical components and 567 potential therapeutic targets of PRP were identified. GO analysis indicated that these targets are mainly associated with peptidyl-tyrosine phosphorylation and steroid metabolic process. KEGG analysis showed that the targets are mainly located in the PI3K/Akt, apoptosis, mitogen-activated protein kinase (MAPK), Ras and vascular endothelial growth factor (VEGF) signalling pathways. According to the p -adjust value, the PI3K/Akt pathway is the core pathway. In vitro, PRPE could inhibit proliferation and induce apoptosis in hepatoma cells. IC 50 values of PRPE were 2.48 and 6.34 mg/mL for BEL-7404 and hepG 2 cells, respectively. PRPE significantly reduced tumour volume and weight. H&E results showed that PRPE repaired necrotic areas in hepatoma cells. PRPE reduced the protein expression of PI3K, Akt1 and Bcl-2 and increased the protein expression of p53 and Bax. Meanwhile, PRPE reduced the mRNA expression of PI3K, AKT1 and BCL 2 and increased the mRNA expression of TP53, CASP3 and BAX. The targets of PRPE are the PI3K/Akt, apoptosis, MAPK, Ras and VEGF signalling pathways. Passing through the PI3K/Akt pathway to induce apoptosis is the main mechanism of PRPE. [Display omitted] • The targets of PRP are mainly located in the PI3K/Akt and apoptosis signalling pathways. • PRPE could induce apoptosis in hepatoma cells. • PRPE reduced the protein expression of PI3K, Akt1 and Bcl-2 and increased the protein expression of p53 and Bax. [ABSTRACT FROM AUTHOR]

This paper presents three embedded episodes in the life of a polyherbal drug indicated as a preventative measure for hangovers. Invented and marketed in 2005 by a leading ayurvedic pharmaceutical company in India, PartySmart is a reformulated compound based on ayurvedic, biomedical and phytochemical sources. This creative process has involved multiple translations, resulting in hybrid pharmacological models, including, for instance, ayurvedic post-digestive tastes and biomedical effects on enzymatic activities. These modes of therapeutic action are conceptualizations of an active drug – i.e. a digested and metabolized drug. A problem arises, however, in the fact that the ingestion of this drug is linked to alcohol consumption in a country where it is widely considered in negative terms. For this reason, PartySmart was seen as an ambivalent presence in the firm's catalogue and thus a series of interventions aiming to uphold the image of this drug transformed both its social inscription and its materiality. This transformation also took a different, global trajectory as the drug gradually developed as a transnational pharmaceutical commodity and became a new object in new latitudes. By focusing on the social and material dimensions of this drug in these contexts, this paper calls upon science studies to expand the scope of pharmaceutical anthropology. It brings together various layers of analysis to offer new perspectives on contemporary herbal formulations as they traverse material cultures, medical epistemologies, sociopolitical borders, legal environments and social practices. [ABSTRACT FROM AUTHOR]

Background: Fenofibrate is a serum lipid-lowering agent used as an adjunct to diet in patients with hypercholesterolemia and hypertriglyceridemia. The new fenofibrate tablet formulation was developed as a pharmaceutical equivalent to the marketed tablet formulation containing 145 mg. Objective: The objective of this study was to compare the pharmacokinetics and safety of 2 tablet formulations containing 145 mg of fenofibrate (CAS number 49562-28-9) in healthy human subjects. Methods: The study was a randomized, 2-treatment, 3-period, 3-sequence, single-dose, 3-way crossover, partial replicate bioequivalence study in healthy human subjects under fasting conditions. Eligible subjects received each treatment in a crossover manner according to the randomization schedule. Replicate dosing was conducted for the reference formulation to determine its intrasubject variability. The predose blood sample was taken within 1 hour before dosing, and serial blood sampling was performed up to 72.0 hours’ postdose. The analysis of plasma samples for concentrations of fenofibric acid, the active metabolite of fenofibrate, was conducted by using a validated LCMS/ MS method. Bioequivalence was to be concluded if the 90% CIs as constructed were within the range of 80% to 125% for Cmax, AUC0-t, and AUC0-∞ for fenofibric acid. Subjects were monitored for safety and tolerability throughout the study. Results: 15 healthy human subjects between 18 and 45 years of age and having body mass index between 18.5 and 30 kg/m2 were recruited into the study. The 90% CIs for the test/reference mean ratios of the lntransformed pharmacokinetic variables Cmax, AUC0-t, and AUC0-∞ were within the conventional bioequivalence range of 80% to 125%. Both formulations were well tolerated after a single oral dose in these healthy male subjects. Conclusions: Both fenofibrate tablet formulations demonstrated equivalent rates and extent of systemic absorption, and hence were considered bioequivalent [ABSTRACT FROM AUTHOR]

Objective. To compare the efficacy and safety of newly developed paracetamol 1,000 mg sustained release ( SR) tablets (test product) with conventional paracetamol 500 mg tablets (reference product) in patients with fever and pain. Design. An open label, multicentric, comparative, randomized, noninferiority trial. Methodology. Eligible patient, as per predefined inclusion and exclusion criteria, were randomized to receive either one tablet of test product twice daily or one tablet of reference product four times a day for 3 consecutive days. Primary efficacy parameter (an antipyretic activity) was measured through recording changes in body temperature while secondary efficacy parameter (an analgesic activity) was measured by recording changes in visual analog scale ( VAS) from the baseline. Safety assessment was done by recording adverse drug reactions occurred during treatment period. Analysis of variance was used for the statistical evaluation of data. Results. Of 500 randomized patients, 249 were received paracetamol 1,000 mg SR tablets (Group-I), and 247 were received conventional paracetamol 500 mg tablets (Group-II). Group-I reported temperature reduction from 101.35 ± 1.23°F to 98.80 ± 0.72°F while temperature reduction in Group-II was from 101.42 ± 1.33°F to 98.9 ± 0.85°F. Group-I reported reduction in mean VAS was from 6.16 ± 2.37 to 1.44 ± 1.70 in comparison to Group-II from 5.97 ± 2.45 to 1.38 ± 1.78. No significant adverse reactions were observed in either group. Conclusion. Both the formulations of paracetamol were clinically and statically equivalent. Paracetamol 1,000 mg SR formulation is noninferior to conventional paracetamol 500 mg tablets. [ABSTRACT FROM AUTHOR]

Summary [ABSTRACT FROM AUTHOR]

The article presents news on pain and pharmacology. An initiative called the Analgesic Clinical Trials Innovations, Opportunities, and Networks (ACTION) initiative is being developed to streamline the discovery and development process for new analgesic drugs. Research published in 2011 in an online publication investigated pharmacological treatments for fatigue in diseases such as cancer. In 2011 the U.S. Food and Drug Administration approved the postherpetic neuralgia drug gabapentin.

Bioassay-guided fractionation of the fruits of Piper longum afforded two new minor amides, piperlongimin A (2) [2E-N-isobutyl-hexadecenamide] and piperlongimin B (4) [2E-octadecenoylpiperidine] together with five known compounds with moderate cytotoxic activity. The structures were elucidated on the basis of spectroscopic evidences. All these compounds inhibited cell proliferation of human leukemia, HL-60 cell lines, and displayed major apoptosis-inducing effects. [ABSTRACT FROM AUTHOR]

A stability-indicating high performance thin layer chromatographic (HPTLC) method for the densitometric analysis of nadifloxacin in microemulsions was developed and validated according to the guidelines of the International Conference on Harmonization (ICH). The compact spot for nadifloxacin was found at an Rf value of 0.39 ± 0.02 at an absorption wavelength of 288 nm using a mobile phase consisting of chloroform : methanol formic acid (7.5 : 2.0 : 0.5 v/v). The linear regression data for the calibration plots (r2 = 0.9981) was found with respect to peak area in the concentration range of 50 - 600 ng/spot. The limit of detection (LOD) and limit of quantification (LOQ) were 9.4 and 20.5 ng respectively. The drug was subjected to acid and alkaline hydrolysis, oxidation, photo degradation and dry heat treatment. The peaks of degradation products were well-resolved from the peak of the standard drug with significantly different Rf values. Statistical analysis revealed that the developed HPTLC method is reproducible, selective and accurate for the determination of nadifloxacin in its formulations. The method can effectively separate the drug from its degradation products and be used for stability-indicating assay. [ABSTRACT FROM AUTHOR]

My professional research career spanning more than four decades has been largely devoted to synthetic medicinal chemistry (Ciba, Bombay -- now Mumbai -- 21 years) followed by an equal number of years in process development of drugs, crop protection chemicals (Searle, Bombay) and drugs and speciality chemicals (Recon and Hikal, Bangalore). These efforts have involved several collaborators including many from other institutions and offered multitudinous challenges calling for continuous creativity in industrial setups. I was fortunate to have had a conducive environment to be able to respond to these challenges. I attempt to offer the readers in the ensuing pages a flavour of the excitement that has marked these years. [ABSTRACT FROM AUTHOR]