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Ex) Article Title, Author, Keywords
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Int J Pain 2024; 15(1): 48-49
Published online June 30, 2024 https://doi.org/10.56718/ijp.24-002
Copyright © The Korean Association for the Study of Pain.
Kanaiyalal Prajapati
Correspondence to:Kanaiyalal Prajapati, Medical Services, Troikaa Pharmaceuticals Ltd., Troikaa House-1, Satya Marg, Bodakdev, Ahmedabad 380054, Gujarat, India. Tel: +91-79-26856242/43/44/45, E-mail: kanaiyalal@troikaapharma.com
Keywords: diclofenac, NSAIDs, pain, pharmacokinetics, topical.
Dear Editor:
Thank you for sending feedback on our manuscript, which appreciated our work showing faster and higher penetration of diclofenac, from Dynapar QPS Plus than Diclofenac Aerosol Spray [1].
We would like to state that this was a two-treatment, two- period, two-sequence, single dose, balanced, crossover and comparative bioavailability study. Subjects were randomly allocated to the RT or TR sequence. Subjects in the RT sequence received treatment R (refers to Diclofenac Aerosol Spray) in the first period, and after a wash out period of 14 days they received treatment T (refers to Dynapar QPS Plus) in the second period. The subjects assigned to the TR sequence received treatment T first and then treatment R. The order of receiving the test or reference formulation for each subject in each period of the study was determined as per the randomization schedule using SAS® software version 9.4. Randomization was done in using PROC PLAN such that the design was balanced. As each subjects act its control, crossover designs are very much helpful as this minimizes inter-subject variations.
We agree with the author on small sample size was used in this study, and the small sample size used in the study can be considered as limitation of this study. However, in this study, we have got more than six time higher penetration of diclofenac from Dynapar QPS Plus than Diclofenac Aerosol Spray. Further in another study carried out in 18 subjects on the product manufactured by same QPS (quick penetration solution) technology, we have got approximately 5 times higher penetration of diclofenac than conventional gel [2]. Thus based on the results of the current study and previous study it is found that there is a huge difference in penetration of diclofenac with products manufactured by QPS technology in comparison to aerosol sprays and gel, therefore it is anticipated that the results would have been similar, had the study been conducted on higher number of subjects.
None.
No potential conflict of interest relevant to this article was reported.
Int J Pain 2024; 15(1): 48-49
Published online June 30, 2024 https://doi.org/10.56718/ijp.24-002
Copyright © The Korean Association for the Study of Pain.
Kanaiyalal Prajapati
Medical Services, Troikaa Pharmaceuticals Ltd., Ahmedabad, Gujarat, India
Correspondence to:Kanaiyalal Prajapati, Medical Services, Troikaa Pharmaceuticals Ltd., Troikaa House-1, Satya Marg, Bodakdev, Ahmedabad 380054, Gujarat, India. Tel: +91-79-26856242/43/44/45, E-mail: kanaiyalal@troikaapharma.com
Dear Editor:
Thank you for sending feedback on our manuscript, which appreciated our work showing faster and higher penetration of diclofenac, from Dynapar QPS Plus than Diclofenac Aerosol Spray [1].
We would like to state that this was a two-treatment, two- period, two-sequence, single dose, balanced, crossover and comparative bioavailability study. Subjects were randomly allocated to the RT or TR sequence. Subjects in the RT sequence received treatment R (refers to Diclofenac Aerosol Spray) in the first period, and after a wash out period of 14 days they received treatment T (refers to Dynapar QPS Plus) in the second period. The subjects assigned to the TR sequence received treatment T first and then treatment R. The order of receiving the test or reference formulation for each subject in each period of the study was determined as per the randomization schedule using SAS® software version 9.4. Randomization was done in using PROC PLAN such that the design was balanced. As each subjects act its control, crossover designs are very much helpful as this minimizes inter-subject variations.
We agree with the author on small sample size was used in this study, and the small sample size used in the study can be considered as limitation of this study. However, in this study, we have got more than six time higher penetration of diclofenac from Dynapar QPS Plus than Diclofenac Aerosol Spray. Further in another study carried out in 18 subjects on the product manufactured by same QPS (quick penetration solution) technology, we have got approximately 5 times higher penetration of diclofenac than conventional gel [2]. Thus based on the results of the current study and previous study it is found that there is a huge difference in penetration of diclofenac with products manufactured by QPS technology in comparison to aerosol sprays and gel, therefore it is anticipated that the results would have been similar, had the study been conducted on higher number of subjects.
None.
No potential conflict of interest relevant to this article was reported.
pISSN 2233-4793
eISSN 2233-4807
Frequency: Semi-Annual
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