ABSTRACT

Background:

Once-weekly therapies like Trelagliptin, a long-acting Dipeptidyl Peptidase-4 (DPP-4) inhibitor, can enhance medication adherence and simplify treatment. Pharmacokinetic data on Trelagliptin in Indians are limited, necessitating a bioequivalence study with the reference product for regulatory approval and therapeutic consistency.

Objective: To evaluate the pharmacokinetics and bioequivalence of the test product, Trelagliptin 100 mg tablet of Zuventus Healthcare Limited, compared to the reference product, Zafatek® (Takeda Pharmaceutical Company Limited, Japan), in healthy Indian adults under fasting conditions.

Methods: This was an open-label, randomized, two-treatment, two-period, crossover, single-dose, truncated, bioequivalence study with a 25-day washout period. Pharmacokinetic parameters (Cmax, AUC0-72, Tmax) were assessed up to 72 hours post-dose. Plasma concentrations were measured using a validated liquid chromatography-tandem mass spectrometry (LC–MS/MS) method. Bioequivalence was established if the 90% confidence intervals (CI) of the geometric mean ratios (GMRs) for log-transformed primary parameters, Cmax and AUC0-72 fell within the 80.00–125.00% acceptance range.

Results: Thirty-two male volunteers were enrolled, and 31 completed the study. The test and reference products demonstrated comparable pharmacokinetic profiles. The GMRs were 104.55% and 102.31% for Cmax and AUC0-72, respectively. The intra-subject coefficient of variation (ISCV) was 23.04% for Cmax and 4.25% for AUC0-72. The 90% CI for Trelagliptin was 94.77–115.34% for Cmax and 100.45–104.20% for AUC0-72, falling within the accepted bioequivalence range. Both products were well-tolerated, with only mild adverse events reported.

Conclusions: Trelagliptin 100 mg tablet of Zuventus Healthcare Limited is bioequivalent to the Originator Product, Zafatek® from Japan and well-tolerated in healthy Indian subjects.

ABSTRACT

Objective: To evaluate the bioequivalence of two oral tablet formulations of edoxaban 60 mg in healthy Indian adults.

Method and material: An open-label, randomized, two-treatment, two-sequence, two-period, single-dose crossover study was conducted under fasting conditions. Eligible subjects received a single 60 mg tablet of edoxaban, either the test formulation (Supexa-ODTM from Zuventus Healthcare Limited, India) or the reference formulation (Lixiana® from Daiichi Sankyo Europe GmbH, Germany). The two doses were separated by a 7-day washout period. Blood samples were collected up to 72 hours post-dose, and the plasma concentrations of edoxaban were detected using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters Cmax, AUC0-t, AUC0-inf, Tmax, t1/2, and Kel were determined. Bioequivalence was assessed by calculating the geometric least square (LS) mean ratios and corresponding 90% confidence intervals (CIs) for these parameters. Safety was evaluated by monitoring adverse events.

Results: Forty subjects were randomized and completed the study. The pharmacokinetic parameters of the test formulation were similar to those of the reference. The 90% CIs of the geometric LS mean ratios of the test to reference for Cmax (86.53-114.53%), AUC0-t (100.87-115.43%), and AUC0-inf (100.38-113.31) fell within the acceptable range of 80.00–125.00%. Both formulations were well tolerated, with no serious adverse events reported.

Conclusions: Both formulations of edoxaban 60 mg tablet were bioequivalent and well-tolerated in healthy Indian adults under fasting conditions. These findings support their interchangeability in clinical practice.

ABSTRACT BACKGROUND:

Asthma and chronic obstructive pulmonary disease (COPD) contribute significantly to the global respiratory disease burden, with treatment adherence and nocturnal symptom control remaining key challenges. The Tulobuterol Transdermal Patch (Tuloplast™) provides continuous 24‑h drug release, potentially improving adherence and symptom management. This Phase‑IV clinical study evaluated its safety, tolerability, and efficacy in patients with asthma and COPD.

METHODS:

This multicentric, open‑label Phase‑IV trial enrolled 300 patients (189 asthma, 111 COPD) across seven Indian centers. Patients received Tuloplast™ in age‑appropriate doses for 4–6 weeks. Primary endpoints included safety and tolerability, assessed by adverse events, global ratings, and rescue medication use. Efficacy (secondary endpoint) was evaluated through symptom severity (GINA/GOLD criteria) and pulmonary function (peak expiratory flow [PEF], forced expiratory volume in 1 second [FEV1 ], forced vital capacity [FVC]), with statistical significance determined using paired t‑tests.

RESULTS:

Only one patient (0.3%) reported an adverse event (mild swelling), with no serious safety concerns. At Day 28, 51.9% of asthma patients and 79.3% of COPD patients rated tolerability as “good,” while 43.9% and 12.6%, respectively, rated it “excellent.” Significant reductions in symptom severity were observed in asthma (P < 0.0001) and COPD patients (P < 0.0001), particularly for nocturnal symptoms (−74.88% for COPD, and −82.79% and −77.29% for pediatric and adolescent patients, respectively). Pulmonary function parameters (PEF, FEV1 , FVC) improved significantly in both groups (P < 0.0001).

CONCLUSION:

Tuloplast™ demonstrated excellent safety, tolerability, and efficacy in improving symptom control and lung function. Its once‑daily application enhances adherence, making it a promising alternative for asthma and COPD management.

Abstract

India faces a growing burden of type 2 diabetes mellitus (T2DM), necessitating innovative treatments that improve glycemic control, reduce glycemic variability (GV), and enhance patient adherence. Dipeptidyl peptidase 4 (DPP-4) inhibitors are established antidiabetic agents; however, once- or twice-daily dosing often limits long-term compliance. Trelagliptin, a novel once-weekly DPP-4 inhibitor, addresses this issue with an extended half-life and superior molecular stability, enabling sustained DPP-4 inhibition and significant GV reduction. Improved glycemic control with trelagliptin can potentially lower the risk of macrovascular and microvascular complications associated with T2DM. Trelagliptin, developed and launched in India by Zuventus Healthcare Limited under the brand name Trelaglip® , offers prolonged efficacy and high selectivity in inhibiting the DPP-4 enzyme, helping minimize side effects. Development began with in-house active pharmaceutical ingredient (API) synthesis, followed by successful formulation and stability studies. A bioequivalence study confirmed pharmacokinetic equivalence with the reference product by Takeda, Japan. In a randomized phase 3 clinical trial involving patients with glycated hemoglobin (HbA1c) ≥8%, trelagliptin showed greater HbA1c reduction (−1.25%) as compared to vildagliptin (−1.15%) and a similar safety profile. Mild adverse events occurred in 6.67% of trelagliptin users compared to 9.17% with vildagliptin. This article outlines the development and regulatory journey leading to trelagliptin’s first approval in India by the Central Drugs Standard Control Organization (CDSCO) in December 2024. Phase 4 real-world evidence studies are currently ongoing in India to assess long-term safety and efficacy.

Abstract

Background

One of the most significant postoperative challenges faced by patients is the occurrence of acute episodes of pain and inflammation, often accompanied by the development of edema, particularly in the case of large wounds. Consequently, any delay in the healing process of such wounds can exert a substantial impact on recovery. This delay can potentially be mitigated by addressing the moisture imbalance at the wound site using proteases, while concurrently minimizing pain and inflammation through the use of appropriate analgesic and anti-inflammatory preparations. The objective of this study was to evaluate the safety and efficacy of Tibrolin® D, a fixed-dose combination comprising trypsin, bromelain, rutoside, and diclofenac tablets, in alleviating pain intensity and enhancing wound healing in patients experiencing acute pain resulting from uncontaminated minor orthopedic surgical procedures or wounds.

Method

An open-label, multicenter, controlled, comparative Phase IV clinical study was conducted on 200 patients who underwent elective, clean, and uncontaminated minor orthopedic surgery. These patients were randomized (1:1) to receive either Tibrolin® D (a combination of trypsin 48 mg, bromelain 90 mg, rutoside 100 mg, and diclofenac 50 mg) or Voveran® 50 GE (diclofenac 50 mg) as one tablet orally, thrice a day postoperatively for seven days. The primary outcome was the proportion of patients reporting adverse events. Secondary outcomes included a total wound symptom score, evaluated based on symptoms after minor orthopedic surgery using a four-point Likert scale, and pain intensity assessed by the Numerical Pain Rating Scale.

Results

No adverse events were observed in this study. Both groups demonstrated statistically significant improvement (p < 0.001) in all assessed wound symptoms: erythema, edema, discharge, induration, local irritation, tenderness, and pain. By Day 7, total wound symptom scores significantly decreased in both the Tibrolin® D group (12.84 ± 2.89 to 2.24 ± 2.08) and the diclofenac group (12.86 ± 3.29 to 2.66 ± 2.28) (p < 0.001), with no significant difference between groups (p = 0.318). Pain intensity also decreased significantly in both groups by Day 7 (p < 0.001), with no significant difference in mean change between groups (p = 0.412). Notably, 91% of patients and 96% of investigators rated Tibrolin® D as good to excellent in relieving wound symptoms, comparable to ratings for diclofenac (88% and 96%, respectively).

Conclusion

Tibrolin® D was as well tolerated as diclofenac, indicating a favorable safety profile. The findings also suggest that Tibrolin® D improves wound healing symptoms and reduces pain intensity following minor orthopedic surgeries, demonstrating efficacy comparable to diclofenac.

The combination of Levodropropizine and Chlorpheniramine Maleate offers a dual-action approach for the symptomatic relief of cough and allergic components in upper respiratory tract infections.

Levodropropizine, a peripheral antitussive, acts at the level of airway sensory nerves to suppress cough without affecting the central nervous system ensuring safety and alertness.

CPM, a first-generation antihistamine, complements this by controlling allergy-related symptoms like sneezing, runny nose, and nasal congestion.

Together, they interrupt the cough-allergy cycle, providing effective and well-tolerated relief in chronic cough associated with RTI, Asthma, Bronchitis. This is also ideal for dry irritating cough associated with allergy, post nasal drip without the drowsiness or dependence associated with central cough suppressants.

Cetirizine drops offer effective and gentle relief from allergic symptoms in infants and young children. As a second-generation antihistamine, cetirizine provides fast onset of action—typically within an hour and ensures 24-hour, relief from conditions like allergic rhinitis, urticaria, and environmental allergies.

With a child-friendly taste and precise weight-based dosing, cetirizine drops are easy to administer and well tolerated, making them a trusted choice for Doctors.

Designed specifically for tiny tummies, they combine safety, efficacy, and comfort in every drop.

Abstract

Background

Trelagliptin and vildagliptin are oral dipeptidyl peptidase-4 (DPP-4) inhibitors used in the treatment of type 2 diabetes mellitus. The administration of vildagliptin is twice daily, whereas trelagliptin provides the convenience of once-weekly dosing, which may enhance patient adherence. A phase 3 clinical trial was conducted to assess the non-inferiority of trelagliptin compared to vildagliptin.

Methods

This multicenter, randomized, open-label, parallel-group, active-controlled non-inferiority clinical trial was conducted at 10 geographically distinct sites across India. A total of 240 treatment-naive patients with type 2 diabetes mellitus were randomized in a 1:1 ratio to receive either trelagliptin (100 mg once weekly) or vildagliptin (50 mg twice daily) for 16 weeks. The primary endpoint was non-inferiority of trelagliptin to vildagliptin in reducing glycated hemoglobin (HbA1c) levels from baseline to week 16. Secondary efficacy measures included changes in fasting and postprandial blood glucose, fasting insulin, glucagon, C-peptide, and glucagon-like peptide-1 (GLP-1) levels. Safety was assessed based on the incidence of adverse events.

Results

At week 16, the mean HbA1c levels were 7.18 ± 1.47% and 7.21 ± 1.49% in trelagliptin and vildagliptin groups, respectively (Δ -0.89% vs. Δ -1.00%, p < 0.0001). The difference between groups was 0.11% (95% CI: -0.28 to 0.50; p = 0.5899), showing non-inferiority of trelagliptin. A total of 48.57% of patients in the trelagliptin group and 47.57% in the vildagliptin group achieved the target HbA1c level of <7% (p = 0.8850). No statistically significant differences were observed between the groups for glycemic parameters, including fasting blood glucose (Δ 1.11; 95% CI: -16.79 to 19.02; p = 0.9025), 2-hr postprandial glucose (Δ 3.33; 95% CI: -30.55 to 23.88; p = 0.8093), fasting serum insulin (Δ 5.22; 95% CI: -15.01 to 25.45; p = 0.6113), fasting glucagon (Δ 0.72; 95% CI: -96.34 to 94.90; p = 0.9882), C-peptide (Δ 0.36; 95% CI: -0.31 to 1.03; p = 0.2912), and GLP-1 levels (Δ -0.02; 95% CI: -0.06 to 0.02; p = 0.3995). All reported adverse events were mild in nature and resolved without any lasting effects. Adverse events occurred in 6.67% (8/120) of patients in the trelagliptin group and 9.17% (11/120) in the vildagliptin group.

Conclusions

Trelagliptin showed a significant reduction in HbA1c, fasting, and postprandial glucose levels, indicating effective glycemic control in patients with type 2 diabetes mellitus. The study drug exhibited a favorable safety profile, with no major adverse events reported. Overall, trelagliptin proved to be both efficacious and well-tolerated, demonstrating non-inferiority to vildagliptin.

Plecasoft contains the active ingredient plecanatide, which works directly in the intestine to help increase fluid and support regular bowel movements. It acts like a natural substance in your body to draw water into the intestines, making stools softer and easier to pass. This makes stools softer and easier to pass. It helps relieve symptoms like hard stools, bloating, and stomach discomfort. Plecasoft is used in adults to treat long-term(chronic) constipation and constipation caused by irritable bowel syndrome (IBS-C).

The combination of ‘Pregabalin and Duloxetine’ is an emerging, fast-growing therapy for Painful Peripheral Neuropathy associated with Mood Disorders. Upnuron-D, offers enhanced efficacy in relieving neuropathic pain while helping regulate mood. Upnuron-D, provides patients with effective pain relief and mood stabilization, promoting overall well-being.