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Sharma V.,All India Institute of Medical Sciences | Madhu S.,Troikaa Pharmaceuticals Ltd | Natarajan P.,Micro Therapeutic Labs Private Ltd | Muniyandi G.,Micro Therapeutic Labs Private Ltd | And 2 more authors.
Clinical and Applied Thrombosis/Hemostasis | Year: 2010

Introduction: India is one of the few countries where biosimilar enoxaparin is available for clinical use. Despite availability since past 4 to 5 years, there is a paucity of published literature regarding their biological activity. The aim of the current study is to compare the biological activity of an endogenously developed formulation of enoxaparin with the branded formulation. Materials and Methods: Twelve healthy male volunteers received 1 subcutaneous injection of 2 different formulations of enoxaparin in a randomized, open-label, balanced, 2-treatment, 2-period, 2-sequence, cross-over study. The test formulation was Injection Troynoxa (enoxaparin sodium 40 mg/0.4 mL, Troikaa Pharmaceuticals Ltd., India) and reference formulation was Injection Clexane (enoxaparin sodium 40 mg/ 0.4 mL, Sanofi-Aventis, UK). The plasma anti-Xa activity and activated partial thromboplastin time (aPTT) were estimated on fully automated coagulometer predose and at 2, 4, 6, 8, and 10 hours following dosing with 40 mg/0.4 mL of enoxaparin. Results: The results of mixed model analysis of repeated measures analysis of variance (ANOVA) for estimating difference between least square means of test and reference formulations, at all time points, showed no significant differences in anti-Xa activity and plasma aPTT levels. Both formulations were well tolerated and there were no bleeding episodes. Conclusion: After a single-dose injection in healthy participants, anti-Xa activities of 2 formulations of LMWH enoxaparin were comparable. No significant difference was observed in the mean plasma aPTT. It remains to be seen whether the 2 formulations would show comparable clinical efficacy. © 2010 The Author(s).


Yaligod V.,Saptagiri Institute of Medical Science and Research Center | Gokul Raj D.,Sri Ramchandra Medical College and Research Institute | Sharma A.B.,Satellite Orthopaedic Hospital | Mallikarjun Swami B.,St Johns Medical College And Hospital | And 5 more authors.
Journal of Clinical and Diagnostic Research | Year: 2014

Materials and Methods: In this randomized, open label, parallel, active controlled clinical study, 250 patients of OA knee meeting inclusion criteria were randomized to receive either PCM 650 dual release two times daily or PCM 500 IR three times daily for 6 weeks. Patients were assessed at baseline, 2, 4 and 6 weeks. Primary efficacy measures were severity of pain (Visual Analogue Scale) and Knee injury and osteoarthritis outcome score (KOOS) subscale for pain at week 2, 4 and 6. Other KOOS subscales (symptoms other than pain, function in daily living, function in sport and recreation, quality of life) and patient’s and physicians global assessment of therapy were included as secondary endpoints.Background: Paracetamol is recommended as first line agent for pain management in osteoarthritis (OA) by various guidelines. The main problem associated with management of osteoarthritis is long term patient compliance to paracetamol due to its frequent dosing.Objective: To evaluate the efficacy and safety of Paracetamol 650 mg dual release tablet twice daily (PCM 650 dual release) compared to paracetamol 500mg immediate release tablet thrice daily (PCM 500 IR) in the treatment of Knee OA.Results: Both treatment groups showed improvement in primary endpoints at each evaluation visit. Patients receiving PCM 650 dual release showed significant improvement of pain in both primary endpoints at each study visit compared to patients receiving PCM 500 IR (p<0.001). PCM 650 dual release was significantly superior to PCM 500 IR for improvement in all KOOS subscales at each study visit (p<0.01). Less number of patients required additional rescue analgesics in PCM 650 dual release group (16% patients vs 26%, PCM 500 IR; p>0.05). Adverse effects were significantly less in PCM 650 dual release group (6% vs. 14% in PCM 500 IR; p<0.05). Patient’s and physician’s global assessment of therapy favoured PCM 650 dual release than PCM 500 IR (p<0.001).Conclusion: Patients with symptomatic OA of the knee showed a greater improvement in pain and functional capacity with PCM 650 dual release than PCM 500 IR with better tolerability. © 2014, Journal of Clinical and Diagnostic Research. All right reserved.


Shep D.,Troikaa Pharmaceuticals Ltd | Ojha A.,Bv Patel Perd Center | Patel S.,Bv Patel Perd Center | Nivsarkar M.,Bv Patel Perd Center | And 3 more authors.
Current Clinical Pharmacology | Year: 2011

Objectives: Diclofenac a non-steroidal anti-inflammatory drug (NSAID) is widely used for the management of various musculoskeletal conditions. An injectable test formulation of diclofenac sodium (75 mg/mL) was prepared to facilitate reduction in injection volume as compared to already marketed formulations of diclofenac sodium (75 mg/3mL). The objective of this study was to compare the bioavailability of test formulation with the reference formulation given intramuscularly in healthy volunteers. Methods: This two way randomized crossover study was performed in 14 healthy, adult, Indian, male human subjects to compare bioavailability. The formulations were administered intramuscularly (intragluteal) to the volunteers in a two way randomized fashion with a wash out period of 6 days. Blood samples were collected till 6.0 h following drug administration. The samples were analyzed using pre-validated HPLC method. Results: The mean C max and T max for the test and reference formulations were 2.14 μg/mL, 1.91 μg/mL and 0.49 h, 0.50 h respectively. The mean AUC 0-t for test and reference formulations were 3.79 μg.h/mL, and 3.43 μg.h/mL respectively. The mean AUC 0-∞ for test and reference formulation were 4.03 μg.h/mL and 3.65 μg.h/mL respectively. The mean (90% CI) C max, AUC 0-t and AUC 0-∞ ratio (Test:Reference) were 1.15 (100.25-132.99), 1.10 (100.34-119.96) and 1.09 (100.78- 118.88), respectively. Conclusion: The test formulation shows a comparable AUC 0-t and AUC 0-∞ but a higher C max in comparison to the reference when given intra-gluteally. The lower volume of the test formulation offers advantage of injection at other sites, like deltoid region. Absence of propylene glycol in the test formulation could be advantageous in terms of improved tolerability. Hence, such formulations of previously well established molecules provide a new direction towards developing better and convenient dosing alternatives. © 2011 Bentham Science Publishers Ltd.


Nivsarkar M.,B. V. Patel Pharmaceutical Education and Research Development Center | Maroo S.H.,Troikaa pharmaceuticals Ltd | Patel K.R.,Troikaa pharmaceuticals Ltd | Patel D.D.,Troikaa pharmaceuticals Ltd
Journal of Clinical and Diagnostic Research | Year: 2015

Introduction: Different topical formulations of diclofenac have varying skin penetration profile. Recent advances in science and technology has led to the development of many new formulations of drugs for topical drug delivery. One such technological development has led to the innovation of Dynapar QPS, a novel, non-aqueous, quick penetrating solution (QPS) of diclofenac diethylamine. Aim: This study was aimed to measure the total exposure from the drug penetrating the skin in healthy human subjects and comparing the relative systemic bioavailability of Dynapar QPS® with diclofenac emulgel. Materials and Methods: A 200 mg of diclofenac from either Dynapar QPS® (5 ml) or emulgel (20 g) was applied on back of subject as per the randomisation schedule. Blood samples were collected up to 16 hours post drug application. Plasma concentration of diclofenac was measured by pre-validated HPLC method. Pharmacokinetic (PK) parameters like Cmax, Tmax, t1/2, AUC0-t, AUC0-∞, and Kel, of diclofenac were determined for both the formulations. Results: Mean Cmaxafter administration of Dynapar QPS® and diclofenac emulgel were 175.93 and 40.04 ng/ml, respectively. Tmaxof diclofenac was almost half with QPS compared to emulgel (5.24 hrs versus 9.53 hrs respectively). The mean AUC0–tand AUC0-∞after administration of Dynapar QPS® was higher as compared to diclofenac emulgel (AUC0–t: 1224.19 versus 289.78 ng.h/ml, respectively; AUC0-∞: 1718.21 versus 513.83 ng.h/ml, respectively). None of the subject experienced any adverse event during the study. Conclusion: The results indicate an enhanced penetration and subsequent absorption of diclofenac from Dynapar QPS® as compared to diclofenac emulgel. Higher penetration is likely to translate into better pain relief in patients. © 2015 Journal of Clinical and Diagnostic Research. All rights reserved.


Bhatnagar S.,All India Institute of Medical Sciences | Devi S.,Kidwai Memorial Institute of Oncology | Vinod N.K.,Rangadore Memorial Hospital | Jain P.N.,Tata Memorial Center | And 3 more authors.
Indian Journal of Palliative Care | Year: 2014

Aim: To compare the efficacy and safety of oral transmucosal fentanyl citrate (OTFC) and oral morphine in Indian patients with breakthrough episodes of cancer pain. Materials and Methods: In this randomized, open label, active controlled, clinical study, total 186 patients who regularly experienced 1-4 episodes of breakthrough cancer pain (BTCP) daily, over the persistent pain controlled by taking oral morphine 60 mg/day or its equivalent were randomized to receive either OTFC 200 mcg or oral morphine 10 mg for the treatment of BTCP for 3 days. Improvement in pain as determined by numerical rating scale (NRS) at 5, 15, 30, and 60 minutes of drug administration and percentage of BTCP episodes showing reduction in pain intensity by >33% at 15 minutes were primary efficacy endpoints. Secondary efficacy endpoints were requirement for rescue analgesia and global assessment by physician and patient. Data of both treatment groups were analysed by appropriate statistical test using software, STATISTICA, version 11. Results: Patients treated with OTFC experienced significantly greater improvement in pain intensity of breakthrough episodes compared to those treated with oral morphine at all assessment time points (P < 0.0001). 56% of breakthrough pain episodes treated with OTFC showed a greater than 33% reduction in pain intensity from baseline at 15 minutes compared to 39% episodes treated with oral morphine (P < 0.0001). Patient's and physician's global assessment favoured OTFC than oral morphine (P < 0.0001). Requirement of rescue analgesia in both the study groups was similar (P > 0.05). Both study drugs were well tolerated. Conclusions: OTFC was found to provide faster onset of analgesic effect than immediate release oral morphine in management of breakthrough cancer pain. © 2014 Indian Journal of Palliative Care.


Shah P.,KEM Hospital | Subnis B.,Sir J J Hospital | Varshney A.,one Urological Research Center | Pradhan C.,Sancheti Institute for Orthopaedics and Rehabilitation Center | And 3 more authors.
International Journal of Clinical Pharmacology and Therapeutics | Year: 2011

Objective: A randomized study comparing efficacy and safety of a new 75 mg/l ml formulation of injection diclofenac sodium designed for intra-deltoid use with the conventional 75 mg/3 ml formulation given intra-gluteal. Design: This was an open-label, multicentric, randomized clinical trial. Methods: A total of 250 adult patients with post-operative pain were randomized to receive either injection diclofenac 75 mg/l ml or diclofenac 75 mg/3 ml. Primary efficacy criteria were time to onset of analgesia and reduction in pain intensity. Severity of pain at site of injection and side effects were also evaluated. Results: 232 patients completed the study. The mean time to onset of analgesia was comparable (16.17 ± 12.70 mm in the diclofenac 75 mg/l ml group and 19.16 ± 11.79 mm in the diclofenac 75 mg/3 ml group). However, significantly more patients achieved analgesia in less than 5 mm and had lesser pain at the site of injection with the 1 ml formulation. The need for rescue medication was also lower with the 1 ml formulation (2.5% vs. 9.82%). No side effects were reported. A significantly larger number of patients and physicians rated the efficacy and safety of injection diclofenac 75 mg/l ml as excellent. Conclusion: Both formulations were effective and safe in the management of post-operative pain with a significantly lower need for rescue analgesia and lower pain at site of injection with diclofenac 75 mg/l ml formulation. The 1 ml formulation had an added advantage of intra-deltoid use. This would specially be helpful in obese/overweight patients with a thick subcutaneous pad of fat over the gluteal region. ©2011 Dustri-Verlag Dr. K. Feistle.


PubMed | Director and Troikaa pharmaceuticals Ltd
Type: Journal Article | Journal: Journal of clinical and diagnostic research : JCDR | Year: 2016

Different topical formulations of diclofenac have varying skin penetration profile. Recent advances in science and technology has led to the development of many new formulations of drugs for topical drug delivery. One such technological development has led to the innovation of Dynapar QPS, a novel, non-aqueous, quick penetrating solution (QPS) of diclofenac diethylamine.This study was aimed to measure the total exposure from the drug penetrating the skin in healthy human subjects and comparing the relative systemic bioavailability of Dynapar QPS() with diclofenac emulgel.A 200 mg of diclofenac from either Dynapar QPS() (5 ml) or emulgel (20 g) was applied on back of subject as per the randomisation schedule. Blood samples were collected up to 16 hours post drug application. Plasma concentration of diclofenac was measured by pre-validated HPLC method. Pharmacokinetic (PK) parameters like Cmax, Tmax, t1/2, AUC0-t, AUC0-, and Kel, of diclofenac were determined for both the formulations.Mean Cmax after administration of Dynapar QPS() and diclofenac emulgel were 175.93 and 40.04 ng/ml, respectively. Tmax of diclofenac was almost half with QPS compared to emulgel (5.24 hrs versus 9.53 hrs respectively). The mean AUC0-t and AUC0- after administration of Dynapar QPS() was higher as compared to diclofenac emulgel (AUC0-t: 1224.19 versus 289.78 ng.h/ml, respectively; AUC0-: 1718.21 versus 513.83 ng.h/ml, respectively). None of the subject experienced any adverse event during the study.The results indicate an enhanced penetration and subsequent absorption of diclofenac from Dynapar QPS() as compared to diclofenac emulgel. Higher penetration is likely to translate into better pain relief in patients.


PubMed | Troikaa Pharmaceuticals Ltd
Type: | Journal: Journal of pain research | Year: 2011

A new propylene glycol-free and reduced-volume formulation of diclofenac sodium 75 mg/mL designed for intradeltoid administration has been found to be bioequivalent to a reference formulation of diclofenac sodium 75 mg/3 mL given via the intragluteal route in normal healthy volunteers. Standard needles may not reach the gluteus maximus muscle in many cases, especially in the obese. The objective of this study was to determine the pharmacokinetic parameters of the new formulation and compare the bioavailability of intradeltoid diclofenac sodium 75 mg/mL with that of the intragluteal 75 mg/3 mL reference formulation in obese volunteers.A comparative, two-way, single-dose, bioavailability study was carried out in 10 obese (body mass index > 25) male Indian volunteers after a washout period of seven days. Blood samples were collected until six hours following drug administration and analyzed using a prevalidated high-pressure liquid chromatography method.The mean maximum plasma concentration and time to reach maximum plasma concentration for the test formulation were 1.30 g/mL and 0.50 hours, respectively, versus 0.93 g/ mL and 1.08 hours for the reference formulation. The mean areas under the curve from 0 to last measurable time point (AUC(0-t)) for the test and reference formulations were 2.71 gh/mL and 2.73 gh/mL, respectively. The mean AUCs from 0 to infinity (AUC(0-)) for the test and reference formulations were 3.71 gh/mL and 3.75 gh/mL, respectively.The results suggest that the test formulation of diclofenac sodium 75 mg/mL has an AUC(0-t) and AUC(0-) comparable with the reference intragluteal formulation of diclofenac sodium 75 mg/3 mL, but with an earlier time to reach maximum plasma concentration and a trend towards a higher maximum plasma concentration. This could be attributed to faster absorption from the deltoid region than from the gluteal region. The test formulation could be helpful in the management of pain in obese or overweight patients and those with dense subcutaneous fat in the gluteal area.


Diclofenac a non-steroidal anti-inflammatory drug (NSAID) is widely used for the management of various musculoskeletal conditions. An injectable test formulation of diclofenac sodium (75 mg/mL) was prepared to facilitate reduction in injection volume as compared to already marketed formulations of diclofenac sodium (75 mg/3 mL). The objective of this study was to compare the bioavailability of test formulation with the reference formulation given intramuscularly in healthy volunteers.This two way randomized crossover study was performed in 14 healthy, adult, Indian, male human subjects to compare bioavailability. The formulations were administered intramuscularly (intragluteal) to the volunteers in a two way randomized fashion with a wash out period of 6 days. Blood samples were collected till 6.0 h following drug administration. The samples were analyzed using pre-validated HPLC method.The mean Cmax and Tmax for the test and reference formulations were 2.14 g/mL, 1.91 g/mL and 0.49 h, 0.50 h respectively. The mean AUC(0-t) for test and reference formulations were 3.79 g.h/mL, and 3.43 g.h/mL respectively. The mean AUC(0-) for test and reference formulation were 4.03 g.h/mL and 3.65 g.h/mL respectively. The mean (90% CI) C(max), AUC(0-t) and AUC(0-) ratio (Test:Reference) were 1.15 (100.25-132.99), 1.10 (100.34-119.96) and 1.09 (100.78-118.88), respectively.The test formulation shows a comparable AUC(0-t) and AUC(0-) but a higher C(max) in comparison to the reference when given intra-gluteally. The lower volume of the test formulation offers advantage of injection at other sites, like deltoid region. Absence of propylene glycol in the test formulation could be advantageous in terms of improved tolerability. Hence, such formulations of previously well established molecules provide a new direction towards developing better and convenient dosing alternatives.


PubMed | Basavatarakam Indo American Cancer Hospital and Research Institute, Troikaa Pharmaceuticals Ltd, Tata Memorial Center, All India Institute of Medical Sciences and 2 more.
Type: Journal Article | Journal: Indian journal of palliative care | Year: 2014

To compare the efficacy and safety of oral transmucosal fentanyl citrate (OTFC) and oral morphine in Indian patients with breakthrough episodes of cancer pain.In this randomized, open label, active controlled, clinical study, total 186 patients who regularly experienced 1-4 episodes of breakthrough cancer pain (BTCP) daily, over the persistent pain controlled by taking oral morphine 60 mg/day or its equivalent were randomized to receive either OTFC 200 mcg or oral morphine 10 mg for the treatment of BTCP for 3 days. Improvement in pain as determined by numerical rating scale (NRS) at 5, 15, 30, and 60 minutes of drug administration and percentage of BTCP episodes showing reduction in pain intensity by >33% at 15 minutes were primary efficacy endpoints. Secondary efficacy endpoints were requirement for rescue analgesia and global assessment by physician and patient. Data of both treatment groups were analysed by appropriate statistical test using software, STATISTICA, version 11.Patients treated with OTFC experienced significantly greater improvement in pain intensity of breakthrough episodes compared to those treated with oral morphine at all assessment time points (P < 0.0001). 56% of breakthrough pain episodes treated with OTFC showed a greater than 33% reduction in pain intensity from baseline at 15 minutes compared to 39% episodes treated with oral morphine (P < 0.0001). Patients and physicians global assessment favoured OTFC than oral morphine (P < 0.0001). Requirement of rescue analgesia in both the study groups was similar (P > 0.05). Both study drugs were well tolerated.OTFC was found to provide faster onset of analgesic effect than immediate release oral morphine in management of breakthrough cancer pain.

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