Stability Indicating Assay for the Determination of Bilastine in Bulk Drug and Method Development Validation by RP-HPLC Using Analytical Quality by Design Approaches Anjali Nayak, R Maria Danish Alwin, G Sangeetha, C Y Sowmya, Yashwanth V Reddy, Raman Dang Indian Journal of Pharmaceutical Education and Research, 2024 Background Regulatory organizations have acknowledged the need for systematic rules for understanding development as a result of the large increase in concerns and criticism regarding the quality and pharmaceutical products. Bilastine is a second generation antihistamine medication. Generally, it is used for treatment of allergic rhino conjunctivitis and urticaria (hives). Objectives The current study outlines the methodical design and validation of a reversed-phase high-performance liquid chromatographic method for the estimation of Bilastine in bulk drugs using AQbD approach. Materials and Methods Using Box Behnken design, the critical method parameters were methodically optimized. Risk estimation matrix was performed and Critical Analytical Attributes, Critical Method Attributes were correlated to identify risk factors of method development. A reverse phase column in isocratic elution mode with mobile phase NaH2PO4 buffer and methanol of different ratio and flow rate 1 mL/min was set for RP-HPLC method development. Results Chromatographic separation was accomplished on INTERSIL C8 column. The optimized and predicted data from JMP PRO 14 software consist of mobile phase 0.1N NaH2PO4 (60%): Methanol (40%), pumped at a flow rate of 1 mL/min gave the higher desirability function of 77%. LOD and LOQ are, respectively, 0.005 mcg/mL and 0.016 mcg/ mL. The Rt of Bilastine was discovered to be 1.894 min. The created method was approved and validated in accordance with ICH Q2 (R1) recommendations. Conclusion The chosen models were determined to be significant with p <0.05. The validation parameter findings were within the permitted range. Forcefully testing the drug’s stability under various stress situations revealed considerable degradation in the presence of heat.
Formulation and Evaluation of Fast Dissolving Tablets of Oxcarbazepine Using Liquisolid Technology Bindhu Booraguntae Mohana, Eswar Gupta Maddi, Raman Dang Indian Journal of Pharmaceutical Education and Research, 2024 Background/Aim The aim of the study was to improve the dissolution profiles of Oxcarbazepine (OXC) from its tablets. This study was done to evaluate the effects of different formulation variables, i.e. type of non-volatile liquid vehicles on oxcarbazepine dissolution rate from its tablets. Materials and Methods The liquisolid tablets were formulated with three different liquid vehicles, namely Polyethylene glycol 200, Propylene glycol and 20% Tween 80 aqueous solution. Micro-crystalline cellulose was used as a carrier material, silicon dioxide as a coating material and sodium starch glycolate as super disintegrate. The empirical method introduced by Spireas and Bolton (1999) was applied strictly to calculate the amounts of coating and carrier materials required to prepare fast dissolving tablets of OXC using liquisolid technique. The tablets passed all the routine quality control tests prescribed by official books. In vitro drug dissolution testing of the liquisolid tablets were done and compared with commercial tablets in 1% SLS solution as dissolution media as per USFDA. Results It was found that the dissolution rate of oxcarbazepine was highest from liquisolid tablets of oxcarbazepine formulated using PEG 200. Differential scanning calorimetry, PXRD and Fourier transform infrared evaluation of our best tablet Formulation (F2) indicated that there is no physico-chemical interaction between OXC and the excipients. Conclusion In vitro dissolution testing, DSC, PXRD and FTIR studies confirmed F2 as the best formulation with respect to drug dissolution rate and revealed that there is no incompatibility between the drug and excipients used in the formulation.
Risk of Respiratory Diseases with Use of Psychotropic Drugs: Results of a Community-based Cross-sectional Study from South India Abhirami Eby, Raman Dang, Elsa Jacob Indian Journal of Pharmaceutical Education and Research, 2024 Abstract: Background: The study evaluated the effect of various psychotropics on pulmonary function to identify the psychotropic drug class most commonly associated with risk of respiratory disorders. Since psychotropic medications have safety concerns for usage in general population, their use in people with Coronavirus Disease (COVID-19) is considered challenging. The study may also serve to draw evidence-based practical recommendations for the treatment of people with COVID-19. Materials and Methods: A 10-item containing questionnaire was designed to capture clinical information regarding psychotropic use and respiratory disorders. Internal consistency and reproducibility were determined using Cronbach’s alpha and intra-class correlation coefficient respectively. A validated questionnaire was administered to patients or caregivers at a community pharmacy setup and data was collected through electronic data capture. All captured data were summarized descriptively and statistically analyzed using R Studio 4.0. Results: Cronbach’s alpha and intra-class correlation coefficient values were found to be 0.92 and 0.85 respectively. In a sample of 198 patients, benzodiazepines were the commonly used medication (43.9%) followed by selective serotonin reuptake inhibitors (21.2%), anti-psychotics (15.1%), mood stabilizers (7.6%) and others (12.2%). A statistically significant association was observed between benzodiazepine, second-generation antipsychotics, and respiratory disorders (OR 1.56 [1.1 – 2.3, p<0.1]). However, the use of first-generation antipsychotics was found to be less associated with respiratory infections. Conclusion: Benzodiazepine and second-generation antipsychotics were found to be significantly associated with respiratory disorders. Hence patients on psychotropics should be monitored for respiratory symptoms and the choice of anti-psychotic medications should be on existing clinical evidence. The psychotropics which were found to be safer through the study can be chosen to improve the quality of psychiatric care in COVID-19 patients, also promoting an optimal management of psychiatric conditions without worsening the medical condition due to COVID-19. Keywords: Psychotropic, Antipsychotics, Respiratory disorder, Pneumonia, COVID-19.
Metal Complexes of Curcumin: A Comprehensive Approach to Design, Synthesis, Characterization and Assessment of Anti-tubercular Activity Paramita Das, Yamuna HM, Harshashree M, Raman Dang Indian Journal of Pharmaceutical Education and Research, 2024 Background: The primary challenge facing Tuberculosis (TB) is the growing prevalence of drug resistance and the hepatotoxicity secondary effects of first and second-line anti-TB treatments have reignited interest in exploring new metal drug complexes as possible sources of anti-TB medications. Aim: To perform in silico studies for Curcumin-metal complexes, synthesis and evaluate their antitubercular activity and cytotoxicity. Materials and Methods: Designed metal complexes were docked against 2NSD and performed ADMET studies. Based on binding affinity, a series of Curcumin-metal complexes were synthesized, characterized by IR, NMR, MASS, P-XRD and the antitubercular activity was evaluated by MABA and MTT assay for cytotoxicity investigations. Results and Discussion: The binding energies ranged from -8.0 to -10.1 ‘ kcal/mol ’ . At -10.1 ‘ kcal/ mol ’ , the Curcumin-Cu complex (C1) exhibited the best binding. The synthesized compounds was evaluated against Mycobacterium tuberculosis (H37Rv) using the MABA assay. Curcumin-Cu complex (C1) showed the highest activity and was the most sensitive at 0.8 µg/mL and showed less toxicity with an IC 50 of 10.0 and a selectivity index of 4.0. Cytotoxicity was evaluated by the ATCC CCL-81 cell line. Conclusion: Therefore, we can conclude that the molecular hit will be a good lead to develop novel therapies for tuberculosis treatment.
Quality by Design Assisted Development of Fast Dissolving Buccal Film of Ivabradine Anushree Sunil Kumar, Kavitha Arenur Narayana Reddy, Rohith Narayana Reddy, Kavya Shivashankar Reddy, Raman Dang Indian Journal of Pharmaceutical Education and Research, 2024 Background Buccal drug delivery is a novel drug delivery system ensure fast onset of action and avoids the first pass metabolism and ultimately improves the bioavailability. Aim The present investigation is oriented towards design and development of Fast Dissolving Buccal Film (FDBF) of Ivabradine HCl (BCS Class I drug) by applying Quality by Design (QbD) concept. Materials and Methods The Quality Target Product Profile was defined for the proposed formulation, CQA’s were identified and risk assessment was carried to identify the most critical factors associated with the formulation development. Main Effect Screening design was applied by using independent variable as HPMC and Kopulan-PG, PEG 400, Tween 80 as material attributes that have an impact on responses such as Folding endurance, Disintegration time, % Drug content and % Drug release at 15 min. The stability data obtained for the optimal formulation was computed in the JMP stability toolbox to predict the expiration date. Results The results of the main effect screening design of 12 formulations indicated that the combined action of three factors had a significant impact on Ivabradine release and could predict the ideal formulation with the necessary Quality target product profile (QTPP). The statistically significant models were determined for % drug release at 15 min (R2=0.97) disintegration time (R2=0.99), folding endurance (R2=0.99) and drug Content (%) (R2=0.98). The optimal formulation confirms the expiration date of 25 months. Conclusion The selected factors and responses have a strong association and are significant enough for formulation optimization, because the highest global desirability value obtained was 0.80.
The Fast and Simple LC-MS/MS Method for Determination of Rifampicin in the Human Blood Plasma V Baskaran, P. D. Chaithanya Sudha, T Abishek, R Hariesh Kumar, G Ramesh, Raman Dang Indian Journal of Pharmaceutical Education and Research, 2024 Background Rifampicin is an important anti tuberculosis drug for the early infection and, more importantly, bactericidal activity against mycobacterium tuberculosis. LC-MS/MS, with the required molecular specificity, provides quantitative method to rapidly differentiate between the drugs and their metabolites. Aim The current study represents the fast and simple LC-MS/MS method for determination of rifampicin in the human blood plasma. Materials and Methods The plasma samples containing the rifampicin drug were cleaned up by using the protein precipitation method. The chromatographic division was performed by utilizing the ZORBAX Eclipse plus C18 Column (4.6 mm X 150 mm, 5μm). The versatile stage comprised of acetonitrile and 10 Mm ammonium acetic acid derivation in a proportion of 80:20% V/V, wash the column with the blend of solvents comprising of acetonitrile and water 80:20% V/V, maintaining column oven temperature at 30°C±1°C and the auto sampler temperature is kept up with at 10°C±1°C. The injection volume of the sample is 10.0 μL and the total run time of the experiment is 4 min with a flow rate of 1000 mL/min and with a split ratio of 50:50 for the entire experiment. Results and Discussion An LC-MS/MS method for the rifampicin from the sample was performed. Sample volume of 0.300 ml, the injection volume is taken as 10.0 μL and total run time is 4 min, RT for rifampicin is 1.30±0.5 min and the reference drug roxithromycin RT is 3.00±0.5 min. Conclusion The transient LC-MS/MS study permits the assessment of enormous quantities of blood tests in a brief timeframe with fast, simple and successful readiness, giving a quick, dependable and best device for RIF clinical observing and review.
Method Development and Validation of Antihypertensive Drugs Using HPLC Technique M.K Ranganath, P D Chaithanya Sudha, Ramesh G, Abishek T, Baskaran V, Hariesh Kumar R, Raman Dang Indian Journal of Pharmaceutical Education and Research, 2024 Aim A validated RP-HPLC method was established for the quantification of Amlodipine and Metoprolol succinate according to ICH guidelines. Materials and Methods This method utilized a Phenomenex (US) C18 column with dimensions of 250X4.6 mm I.D and a particle size of 5 µm. Employing an isocratic elution technique, the mobile phase comprised pH 3.0 phosphate buffer solution and acetonitrile. Detection occurred at a wavelength of 215 nm and a flow rate of 1 mL/min was chosen to ensure optimal resolution for Amlodipine and Metoprolol succinate. Results and Discussion Retention times were noted at 3.137 min and 5.672 min for Amlodipine and Metoprolol succinate, respectively. High correlation coefficients were achieved (0.9995 for Amlodipine and 0.9996 for Metoprolol succinate). The method exhibited precision, with low relative standard deviations of 0.357% for Amlodipine and 0.077% for Metoprolol succinate. In summary, the RP-HPLC method developed was specific, linear, precise and robust. Conclusion The devised method was validated in terms of accuracy, precision, linearity, specificity, robustness and ruggedness. All formulations’ sample recoveries were in good accordance with the claims made on their labels
Ethanolic Extract of Equisetum arvense: A Potential Agent against Rheumatoid Arthritis in Wistar Rats with Freund's Complete Adjuvant-Induced Arthritis Franco Gohain, Jyothi Yachamaneni, Prasanthi Kallepalli, Nishanth Ramesh, Mayukh Sarkar, Syed Sohaila, Raman Dang Indian Journal of Pharmaceutical Education and Research, 2024 Background Rheumatoid arthritis, a global autoimmune affliction affecting 0.3-1% of the population, is characterized by chronic inflammation and systemic symptoms. Dissatisfaction with conventional treatments leads individuals with chronic pain in rheumatoid arthritis to explore alternative medicine. Herbal remedies, including Equisetum arvense extract, are studied for their anti-inflammatory potential. Aim This research focuses on evaluating the impact of E. arvense extract on experimentally induced rheumatoid arthritis in rats, presenting a promising alternative for complementary approaches. Materials and Methods In the study, rats received oral doses of Equisetum arvense ethanolic extract at 50 mg/kg and 100 mg/kg, followed by induction with Complete Freund’s Adjuvant in the hind paw on day 0. Physical parameters like body weight and paw volume were assessed on days 0, 8, 16 and 22. Hematological parameters, including RBC count, Hb levels, ESR, total WBC count, and platelet count, were measured. Histopathological studies were conducted for a comprehensive assessment. Results They showed both doses of Equisetum arvense extract significantly reduced paw volume compared to the CFA-induced group. Extract administration elevated RBC and Hb levels, approaching normalcy. Increases in WBC count and ESR were notably mitigated. Rats treated with the extract demonstrated protection against bone deterioration and reduced soft tissue swelling. Hispathology of tibiotarsal joints E. arvense treated rats exhibited joint protection, reducing cartilage destruction and decreased vascularity. Conclusion The Equisetum arvense showed diminished cartilage destruction and decreased vascularity compared to arthritic rats. The Equisetum arvense exhibits potent anti-rheumatoid activity, emphasizing its potential as an alternative therapeutic approach for rheumatoid arthritis.
Quality by design based development of etravirine self micro emulsifying drug delivery system KAVITHA A. N., JANAKIRAMAN K., RAMAN DANG International Journal of Applied Pharmaceutics, 2021 Objective: The main objective of the present research work was to develop systematically the Self Micro Emulsifying Drug Delivery system of BCS Class IV drug in a Quality by Design framework.
 Methods: The quality by design-based formulation development proceeds with defining the Quality Target Product Profile and Critical Quality Attributes of dosage form with appropriate justification for the same. The statistical Mixture design was used for the development of the formulation. The independent variables selected for the design were Oleic acid, Labrasol and PEG 6000, whereas droplet size (nm), emulsification time (sec), % drug loading and % drug release at 15 min were considered as the potential quality attributes of the Self Micro Emulsifying System. The eight different batches of Etravirine-Self Micro Emulsifying systems (ETV-SMEDDS) were prepared and checked for the Critical Quality Attributes. The simultaneous optimization of the formulation was done by the global desirability approach.
 Results: The characterization report obtained for all the different batches of formulation was analyzed statistically by fitting into regression models. The statistically significant models determined for droplet size (nm) (R2= 0.96 and p-0.1022), emulsification time (sec) (R2= 0.99 and p-0.0267), % drug loading (R2= 0.93 and p-0.1667) and % drug release at 15 min (R2= 0.96 and p-0.0911) and were statistically significant. The maximal global desirability value obtained was 0.9415 and the value indicates, the selected factors and responses have a good correlation and are significant enough for optimization and prediction of best formulation.
 Conclusion: The QbD approach utilized during the development of ETV-SMEEDS facilitated the identification of Critical Material Attributes and their significant impact on the Critical Quality Attributes of SMEDDS. The concept of building quality into product through the QbD application was utilized successfully in the formulation development.
Dynamic method for liaison of community pharmacists with national programme for tuberculosis control: Efforts to harness untapped opportunities Rajeswari Ramasamy, Guru Prasad Mohanta, Shobha Rani R Hiremath, Chandramouli Ramnarayanan, Raman Dang, Manjiri S Gharat Indian Journal of Pharmaceutical Education and Research, 2020 Context: Revised National Tuberculosis Control Program (RNTCP) Directly Observed Treatment-Short course (DOTS) strategy to involve Community Pharmacist (CPs), was conceived and implemented in India, with the objective of improving accessibility of Tuberculosis free medicines. Though the RNTCP personnel in the study area had tried to create liaison with CPs; and to train them in DOTS provision roles, it was not successful as CPs were not forthcoming to be a part RNTCP DOTS paradigm. Hence this study was ideated and executed to develop a liaison model between CP and RNTCP personnel, to support the delivery of DOTS treatment under RNTCP programme. This article discusses the liaison method followed by the researchers to integrate the CPs with RNTCP’S TB centres in Bangalore City. Aim: To establish liaison between community pharmacists and RNTCP personnel to strengthen Public Private Mix (PPM) Partnership for providing TB care role in Bengaluru City, India. Methodology: An educational interventional study involving CPs in Bengaluru City was conducted with the regulatory support from Drugs Control department, Karnataka.Awareness and Training was given on the basis of the RNTCP training module for Community Pharmacist. The change in the level of awareness on existence of PPM RNTCP strategy among community pharmacist; and the percentage of pharmacists showing interest for TB care role after the program was measured. Results and Discussion: Out of 125 CPs representations, 93 CPs enrolled them as Private DOTS providers immediately after programme. The change in the Level of Awareness on the existence of TB-DOTS provider role was found to be 100% in this study. This result clearly points to the fact that CPs needs to be sensitized. Conclusion: The policy level changes in the ease of enrolling CPs to be a DOTS provider under the aegis of drugs control department, needs to be revisited and rethought in RNTCP’s national strategy for pharmacists.
Model predictive control based closed loop drug infusion device in critical care setups using computational therapeutics – A modelling and simulation study International Journal of Pharmaceutical Research, 2019
Evaluation of potency of sweetness of a natural plant based drug, Stevia rebaudiana with human subjects from cultivated field of Shimoga, Karnataka Journal of the Indian Chemical Society, 2018
Infusions of potent vasoactive drugs using computational therapeutic models in critical care setups - A modeling and simulation study Asian Journal of Pharmaceutics, 2018
Acute oral toxicity studies of antipsoriatic herbal mixture comprising of aqueous extracts of Calendula officinalis, Momordica charantia, Cassia tora and Azadirachta indica seed oil Thai Journal of Pharmaceutical Sciences, 2009
Influence of bio-fertilizers on the availability of nutrients (N, P and K) in soil in relation to growth and yield of Stevia rebaudiana grown in South India International Journal of Applied Research in Natural Products, 2008
In vitro establishment and maintenance of callus of Taxus wallichiana Zucc. for the production of secondary metabolites Natural Product Radiance, 2008
Antibacterial activity of antipsoriatic herbs: Cassia tora, Momordica charantia and Calendula officinalis International Journal of Applied Research in Natural Products, 2008
