Alkem (India)

Nimesulide, a potent nonsteroidal anti-inflammatory drug (NSAID), has garnered attention for its distinct mechanism of action, characterized by its selective inhibition of cyclooxygenase-2 (COX-2) and multifaceted pharmacological properties. Extensive clinical evidence supports its safety and efficacy in addressing acute pain syndromes. In this comprehensive review, we undertake a thorough examination of various dimensions surrounding nimesulide, encompassing its historical evolution, intricate mode of action, pharmacokinetic attributes, clinical efficacy in managing acute pain, and notably its safety profile. The historical backdrop of nimesulide's development and evolution is explored, shedding light on the contextual framework of its emergence as a therapeutic agent. A detailed elucidation of its molecular mechanisms elucidates its preferential COX-2 inhibition and its impact on inflammatory pathways, providing insights into its efficacy in pain modulation. Furthermore, a comprehensive analysis of nimesulide's pharmacokinetic properties is provided, highlighting its absorption, distribution, metabolism, and excretion dynamics, which contribute to its clinical efficacy and safety profile. This review meticulously evaluates the clinical evidence supporting nimesulide's effectiveness in alleviating acute pain across various etiologies. Moreover, particular emphasis is placed on scrutinizing its safety profile, drawing comparisons with other NSAIDs. Through a critical synthesis of available data, nimesulide emerges as possessing a favorable safety profile, distinguishing itself from its counterparts in terms of gastrointestinal and cardiovascular tolerability. In conclusion, this review underscores the promising safety and efficacy profile of nimesulide in the management of acute pain, positioning it as a valuable therapeutic option. The positive benefit-to-risk evaluation further reinforces its utility in clinical practice, offering clinicians a well-founded choice for addressing acute pain syndromes effectively.

This study aimed to compare efficacy, safety, and immunogenicity of the biosimilar ranibizumab in comparison with the Innovator Ranibizumab in treatment-naive patients with neovascular (wet) age-related macular degeneration (nAMD or wAMD). This comparative, double blind, multicentre, Phase III clinical study randomized eligible patients in a 3:1 ratio to receive either OPTIMAB® (Alkem Laboratories Ltd./ Enzene Biosciences Ltd.) or Innovator Ranibizumab. Intravitreal injections of Innovator Ranibizumab (0.5 mg in 0.05 mL) and OPTIMAB® (0.5 mg in 0.05 mL) were administered every four weeks for 12weeks (three doses). Primary efficacy endpoints included loss of <15 letters from baseline, gain of ≥15 letters from baseline in visual acuity, mean change in best corrected visual acuity (BCVA) from baseline, and change in central subfoveal thickness (CSFT) from baseline at week 12. Safety was assessed through monitoring of adverse events (AEs) and serious adverse events (SAEs) throughout the study. Overall, of the 152 patients randomized, 141 (92.8%) patients (mean age, 66.6 ± 9.37 years) completed the study. Percentage of patients who lost < 15 letters in BCVA at week 12 from baseline was comparable in both the groups (100.0%, each). On secondary end point analysis, the two groups had comparable mean changes in BCVA (OPTIMAB®, 11.8 ± 9.18; innovator ranibizumab, 12.9 ± 10.29; P =0.5509); proportion of patients who gained ≥ 15 letters in visual acuity (OPTIMAB®, 32.18%; innovator ranibizumab, 25.74%; P = 0.4785) and mean change in CSFT (OPTIMAB®, -76.6 ± 89.03; Innovator ranibizumab, -73.1 ± 92.23μm; P = 0.8422) at week 12 as compared to baseline. OPTIMAB® and innovator ranibizumab demonstrated comparable safety over the 12-week treatment period and no patient expressed anti-ranibizumab antibody in either group patient. Biosimilar ranibizumab (OPTIMAB®) was non-inferior to innovator ranibizumab in terms of efficacy, safety, and immunogenicity in the patients of nAMD.

Cefotaxime and ceftriaxone are two prominent third-generation cephalosporin antibiotics, which are a class of antimicrobial agents with overlapping antibacterial spectra and therapeutic indications, commonly used in treating severe bacterial infections, including meningitis, sepsis, and respiratory tract infections. Despite their shared antibacterial coverage, these antibiotics differ significantly in their pharmacokinetic characteristics such as half-life, protein binding, and tissue penetration. This comprehensive review systematically compares the pharmacokinetic profiles, pharmacological attributes, clinical efficacy, and safety profiles of cefotaxime and ceftriaxone. It further highlights the importance of understanding the nuanced differences between cefotaxime and ceftriaxone, particularly in clinical settings such as intensive care units or during pediatric treatment, where rapid bactericidal action or prolonged drug activity might influence therapeutic outcomes. While their overlapping spectrums offer versatility, clinicians should consider these distinct pharmacokinetic attributes and associated clinical outcomes to guide optimal antibiotic selection.

BackgroundDue to the progressive decline in β-cell function, it is often necessary to utilize multiple agents with complementary mechanisms of action to address various facets and achieve glycemic control. Thus, this study aimed to evaluate the efficacy and safety of a fixed-dose combination (FDC) of metformin/sitagliptin/pioglitazone (MSP) therapy vs. metformin/sitagliptin (MS) in type 2 diabetes mellitus (T2DM).MethodsIn this phase 3, multicenter, double-blind study, patients with T2DM who exhibited inadequate glycemic control with HbA1c of 8.0–11.0% while taking ≥1500 mg/day metformin for at least 6 weeks were randomized to receive either FDC of MSP (1000/100/15 mg) or MS (1000/100 mg) per day for 24 weeks. The primary outcome measure was the change in HbA1c, and secondary outcomes included changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and body weight from baseline to 24 weeks along with safety and tolerability.ResultsAmong the 236 patients randomized, 207 (87.71%) successfully completed the study. All baseline characteristics were comparable between the FDC of MSP and MS groups. There was a subsequent significant reduction of HbA1c in FDC of MSP (− 1.64) vs. MS (− 1.32); between groups was [− 0.32% (95% CI, − 0.59, − 0.05)], P = 0.0208. Similar reductions were found in FPG [− 13.2 mg/dL (95% CI, − 22.86, − 3.71)], P = 0.0068, and PPG [− 20.83 mg/dL (95% CI, − 34.11, − 7.55)], P = 0.0023. There were no significant changes in body weight. A total of 27 adverse effects (AEs) and one severe AE were reported, none of which were related to the study drug.ConclusionThe FDC of MSP demonstrated significant efficacy in managing glycemic indices and could serve as a valuable tool for physicians in the management of Indian patients with T2DM.Trial registrationClinical Trials Registry of India, CTRI/2021/10/037461.

ObjectivesPrefilled syringes (PFS) may offer clinical and economic advantages over conventional parenteral medication delivery methods (vials and ampoules). The benefits of converting from vials and ampoules to PFS have been explained in previous drug-specific economic models; however, these models have limited generalisability to different drugs, healthcare settings and other countries. Our study aims to (1) present a comprehensive economic model to assess the impact of switching from vials to PFS delivery; and (2) illustrate through two case studies the model’s utility by highlighting important features of shifting from vials to PFS.MethodsThe economic model estimates the potential benefit of switching to PFS associated with four key outcomes: preventable adverse drug events (pADE), preparation time, unused drugs, and cost of supplies. Model reference values were derived from existing peer-reviewed literature sources. The user inputs specific information related to the department, drug, and dose of interest and can change reference values. Two hypothetical case studies are presented to showcase model utility. The first concerns a cardiac intensive care unit in the United Kingdom administering 30 doses of 1 mg/10 mL atropine/day. The second concerns a coronavirus (COVID-19) intensive care unit in France that administers 30 doses of 10 mg/25 mL ephedrine/day.ResultsTotal cost savings per hospital per year, associated with reductions in pADEs, unused drugs, drug cost and cost of supplies were £34 829 for the atropine example and €104 570 for the ephedrine example. Annual preparation time decreased by 371 and 234 hours in the atropine and ephedrine examples, respectively.ConclusionsThe model provides a generalisable framework with customisable inputs, giving hospitals a comprehensive view of the clinical and economic value of adopting PFS. Despite increased costs per dose with PFS, the hypothetical case studies showed notable reductions in medication preparation time and a net budget savings owing to fewer pADEs and reduced drug wastage.

Theoretical basis The case dwells with the following theoretical concepts: Appreciate the different need dimensions required to motivate different employee types based on need theory (Alderfer, 1969). Identify the functional needs as per Maslow’s need hierarchy (Hall &amp; Naougaim, 1968) for the permanent and contractual workers. Outline why only hygiene factors are insufficient to arrest worker absenteeism during a pandemic like COVID-19. Apply need theory and “Herzberg’s two-factor theory” (Herzberg, 1966; Herzberg et al., 1957) to enumerate the measures that need to be implemented to build supply chain resilience by reducing absenteeism by motivating employees. Research methodology The case is based on primary research carried out by the authors at Alkem Laboratories Ltd., Sikkim unit in India, during the COVID-19 pandemic that hit the company leading to high absenteeism of contractual workers. Case overview/Synopsis Alkem Laboratories Ltd. is a leading pharma major from India with a global footprint. At the break of COVID-19 pandemic, the manufacturing unit of the company at Sikkim is facing the scare of mass absenteeism, especially among the contractual workers who account for 60% of the workforce of the unit. Ashok Priyadarshi (Vice President, Human Resources) and his team along with the think tank of the unit have to find a solution to the problem at hand. What shall be the measures that the think tank will propose? The team sets out to find an answer to these questions so that Alkem could seize the business opportunity at the wake of the COVID-19 pandemic. Complexity academic level The case is suitable for undergraduate- and graduate-level courses in organizational behavior, organizational change and development and supply chain risk management. The case can also be positioned for executive education and training modules in companies on employee motivation and commitment.

The immune system is a fundamental part of human protection against infection and disease.The immune system can occasionally lead to unfavourable reactions in the host which are known as hypersensitivity reactions. The exaggerated immune reactivity (hypersensitivity) to certain environmental substances (allergens) like airborne pollens, dust, mites, pet dander, and reactions to certain foods that normally have little effect on most people is known as allergy. The incidence of allergic disease like allergic rhinitis (AR), food borne allergy, asthma and anaphylactic reactions are prevalent in 25% of populations predominately in adolescents and adults in industrialised countries. Bilastine is a novel second-generation non-sedative, highly selective histamine H1 receptor antagonist that suppresses some allergic inflammatory processes that inhibits the release of histamine from mast cells and is approved in the treatment allergic rhinitis, urticaria and pruritus associated with skin diseases. This review covers the safety, efficacy and pharmacological aspects of Bilastine as an important product for treatment of allergic rhinitis.

Objective: The present investigation helps to isolate the seed mucilage of Lepidium sativum by using an economic extraction process with utmost yield. Diligence effort was given to get the maximum yield of the mucilage with good flow properties without affecting the intrinsic properties of the extracted mucilage. The yield of the seed mucilage of Lepidium sativum was optimized by using a quality by design approach. The full factorial design was used using three variables (pH of extract, water to seed ratio, and drying temperature) at two levels (high and low). Overall, ten formulation trials were generated through statistical software Minitab placing 2 center points, 1 replicate, and 1 block. All trials were executed to evaluate the percentage yield.&#x0D; Results: The extraction process was evaluated with different solvents (such as ethanol and acetone) and different techniques to monitor the yield of the process. The maximum yield was achieved by soaking Lepidium sativum seeds in water (1:30 ratio), maintaining an alkaline pH, blending by hand blender, and using acetone as a solvent. A factorial design was used to observe the responses like the yield of the isolated mucilage for different levels of all the independent variables. A polynomial equation was developed and model plots (contour plot and Pareto chart) were generated to study the impact of the critical variables on the response yield. ANOVA analysis of the model suggested that the independent variables had significantly affected (p &lt; 0.05) in predicting the response (% yield) and the coefficient terms with a p-value less than 0.05 had a significant effect on the prediction efficacy of the model. Finally, the optimized parameter was established based on statistical evaluation obtained from the polynomial equation as well as the recommendation obtained from the response optimizer. The study indicates that the obtained linear regression equation has a linear relation with a regression coefficient of 0.9869 % for response % yield.&#x0D; Conclusion: A cost-effective extraction and isolation process was established to extract the seed mucilage of Lepidium sativum with maximum yield. The isolated mucilage was evaluated for flow properties and demonstrated that it is having good flow properties and can be used as an excipient or adjuvant in different pharmaceuticals and food industries. The applicability of factorial design was well demonstrated to optimize the yield by optimizing the critical factors.

PurposeThis paper aims to explore the experience of adoption of digital marketing and related tools by restaurant entrepreneurs or owners of restaurants in the UK and India.Design/methodology/approachThis study is based on qualitative research. In-depth interviews were conducted with restaurant owners to understand the extent of adoption of digital marketing tools and how they have embraced the digital change in running their business operations.FindingsFindings shed light on major changes in consumer behaviour and the readiness of restaurant owners to adopt digital tools for marketing restaurant businesses. Additionally, this paper also probes restaurant owners’ apprehensions in the process with an objective of retaining customers for a longer period.Originality/valueIt is also evident that there is a clear gap in the restaurant space in India and the UK as far as the adoption of digital marketing tools is concerned. The restaurants in India are yet to adequately harness the digital medium as a strategic tool for marketing. This research can potentially form the basis of further research in terms of using technology and digital tools to reach customers and creating a more personalized experience for them.