https://orcid.org/0000-0002-7565-301X
Peer Review History
| Original SubmissionDecember 29, 2021 |
|---|
|
PONE-D-21-37028Construction of Sublingual Trilaminated Eszopiclone Fast Dissolving Film for Treatment of Insomnia: Formulation, Characterization and In-vivo Clinical Comparative Pharmacokinetic Study in Healthy Human Subjects.PLOS ONE Dear Dr. Teaima, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Mar 14 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, José das Neves Academic Editor PLOS ONE Journal Requirements: Journal requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and 2. Please amend your Methods section to state the name of your Institutional Review Board and to state any inclusion/exclusion criteria for participants. 3. We noticed you have some minor occurrence of overlapping text with the following previous publication(s), which needs to be addressed: - https://pubmed.ncbi.nlm.nih.gov/24015378/ In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the methods section. Further consideration is dependent on these concerns being addressed. 4. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide 5. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly Reviewer #2: Partly ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: No ********** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No Reviewer #2: No ********** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: No Reviewer #2: Yes ********** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Few comments are as follows: 1) pH word in abstract should be corrected. 2) Heading for 2.2.2, what is tril? 3) Please explain rational for selections of polymer concentration. It is based on Literature search or placebo trials. 4) 2.2.4 : In which layer and when drug should be added is not mentioned. 5) 2.2.5, sandwich approach is good but is drug migration occurs from middle to end layer? 6) P from petri plates should be small at many places. 7) Is for testing in volunteers any ethical approval taken? 8) Why ariprirazole is selected as IS? 9) Line 276, page 14. Gives characteristics of buccal film. Is film described in this manuscript buccal or dissolving? 10) Line 317, page 16, says results are due to polysaccharide properties of pullulan. But maximum good taste is shown by F4 having sodium alginate as polymer. Explain. 11) Figure 1 showed DSC thermogram of excipients and 1 physical mixture. It is physical mixture with which excipient? For better understanding of interaction, authors should show physical mixtures of drug with all other polymers. 12) LC-MS/MS chromatogram of drug and IS should be shown. 13) Statistical analysis is explained but not seen in discussion , in figures please include. Reviewer #2: This is an interesting paper about formulation of eszopiclone oral film. The paper contains manufacturing of films, in vitro evaluations and test in healthy volunteers. The paper is designed suitably. The main concern is that films disintegrated over 10 minutes, much longer than fast dissolving oral films. These cannot be called fast dissolving oral films, as this type of films disintegrate less than one minute. Therefore, with this long disintegration time, how can they be beneficial to patients? The comments are as the following: 1. There are paragraphs in the Introduction that do not cite references such as the last paragraph in page 3. Also, there is an incomplete sentence on page 3 line 60, and line 68, “better” should be replaced with “bitter”. 2. Could the authors please specify the calibration curve characteristics of eszopiclone for UV measurements on page 8. 3. Were ethics obtained to test the taste of films in volunteers and what were exclusion and inclusion criteria? 4. It is claimed on page 11, Line 225 that the LC-MS data were validated, where is the data or reference? What were the limit of detection and limit of quantification? 5. Please use past tense for line 257. 6. Line 284, please cite a reference. 7. How did the volunteers hold a film for 10 minutes in the mouth, did they chew them and then swallow? 8. Did the authors obtain GMP grades of active ingredient and excipients to prepare the oral films for volunteers? Who supplied these? 9. A statistical method is described in the Method section but the results are not presented. ********** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.
|
| Revision 1 |
|
Construction of Sublingual Trilaminated Eszopiclone Fast Dissolving Film for Treatment of Insomnia: Formulation, Characterization and In-vivo Clinical Comparative Pharmacokinetic Study in Healthy Human Subjects. PONE-D-21-37028R1 Dear Dr. Teaima, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, José das Neves Academic Editor PLOS ONE Additional Editor Comments (optional): Please address the comment of Reviewer #1 regarding language during proofing of the article. Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #2: All comments have been addressed ********** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ********** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ********** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: (No Response) Reviewer #2: Yes ********** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Comments for ‘Construction of Sublingual Trilaminated Eszopiclone Fast Dissolving Film for Treatment of Insomnia: Formulation, Characterization and In-vivo Clinical Comparative Pharmacokinetic Study in Healthy Human Subjects.’ Ref. No. PONE-D-21-37028R I thank the editor for giving me an opportunity to review this manuscript. All major corrections are done but still language is required to improve. Eg pg 16 of manuscript, line 318 -So it is Require special packaging for products stability and safety’ this can be written as Special packaging is required for stability and safety of product. Please note, paper can be accepted after minor /grammatical correction, no need to review again. Reviewer #2: Dear authours many thanks for addrssing the points and making alterations in the manuscript. It is an interesting study. ********** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: Yes: Dr Touraj Ehtezazi, Reader in Pharmaceutics |
| Formally Accepted |
|
PONE-D-21-37028R1 Construction of Sublingual Trilaminated Eszopiclone Fast Dissolving Film for the Treatment of Insomnia: Formulation, Characterization and In vivo Clinical Comparative Pharmacokinetic Study in Healthy Human Subjects Dear Dr. Teaima: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. José das Neves Academic Editor PLOS ONE |
Open letter on the publication of peer review reports
PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.
We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.
Learn more at ASAPbio .