PONE-D-20-27192

Stability of extemporaneously prepared Sitagliptin Phosphate Solution

PLOS ONE

Dear Dr. Zaid,

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.

==============================

Based on the reviewer recommendation, the manuscript need certain major revision before consider it for publication.

==============================

Please submit your revised manuscript by Nov 30 2020 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:

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• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled '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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Girish Sailor

Academic Editor

PLOS ONE

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[The authors would like to acknowledge An-Najah National University for its support]

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[The authors have declared that no competing interests exist].   

We note that one or more of the authors are employed by a commercial company: Pharmacare PLC

1. Please provide an amended Funding Statement declaring this commercial affiliation, as well as a statement regarding the Role of Funders in your study. If the funding organization did not play a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript and only provided financial support in the form of authors' salaries and/or research materials, please review your statements relating to the author contributions, and ensure you have specifically and accurately indicated the role(s) that these authors had in your study. You can update author roles in the Author Contributions section of the online submission form.

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If your commercial affiliation did play a role in your study, please state and explain this role within your updated Funding Statement.

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5.We noticed you have some minor occurrence of overlapping text with the following previous publication, which needs to be addressed:

- https://insights.ovid.com/eujhph/201705000/01735171-201705000-00005

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.

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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: No

Reviewer #2: Yes

**********

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: Yes

**********

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: The above manuscript describes a method to evaluate the Stability of Extemporaneously Prepared Sitagliptin Phosphate Solution for patients with swallowing difficulties or need feeding tubes to take medicines. The research topic is interesting; however, it should be noted out that the manuscript exhibits many shortcomings and errors. Some are summarized below:

Abstract: Line 31, Replace the word “champers” with “chambers”

Abstract: Line 34, Replace the word “validates” with “validated”

Introduction: Line 55, Delete the word “phosphate”

Introduction: Line 59, The word “Mellitus” should be written as mellitus

Materials and Methods: Line 82-85, Repetition of the word “Pharmacare PLC”

Materials and Methods: Line 93, Incubator was used as stability chamber for stability studies. How temperature and humidity can be varied simultaneously in an incubator? ICH guideline was not followed while carrying out stability studies.

Materials and Methods: Line 95, “Three samples were taken for initial analysis”, however, in Abstract 4 types of samples were mentioned (eg. T1, T2, T3 and T4). Which version is correct (3 or 4)?

Materials and Methods: Line 100, Table 1, Procedure for preparing 1 % solution of Sitagliptin Phosphate solution was not correct.

Materials and Methods: Line 102, “Five gram” precisely of the drug was dissolved in 30 mL distilled water. Whereas, in Table 1, 6.4 g was mentioned.

Materials and Methods: There was no mention of mobile phase ratio in the entire manuscript, which is primary requirement for method to reproduce.

Materials and Methods: The method sample preparation was not satisfactory

Materials and Methods: Authors have not mentioned procedure for performing validation parameters, therefore, it is not possible to judge whether ICH guidelines were followed or not.

Results: Line 185, The pH was mentioned as “3 ± 0.15”, whereas, in Table 2, pH was in the range of 3-4.

Results: Presentation of data and statistical analysis are not as per regulatory guidelines. Data’s presented in Table 2, 4 and 5 are not as per ICH guidelines

Results: Chromatograms presented at the end of the manuscript are not visible properly and does not reflect the result or outcome of the study.

Reviewer #2: Research article should be recommended after such correction. Author doing good research work in the area of pharmaceutical formulation development and for the same he/she also develop a good HPLC metho.

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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.

Attachments

Attachment

Submitted filename: Comment Sheet.docx

PONE-D-20-27192R1

Stability of extemporaneously prepared Sitagliptin Phosphate Solution

PLOS ONE

Dear Dr. Zaid,

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.

==============================

As per the reviewer's comment, the manuscript need major revision before consider for publication.

==============================

Please submit your revised manuscript by Apr 11 2021 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:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled '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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Girish Sailor

Academic Editor

PLOS ONE

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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 #3: (No Response)

**********

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 #3: No

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #3: No

**********

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 #3: No

**********

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 #3: No

**********

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 #3: After going through the revised manuscript, these are my observations:

Major problems:

#1. As pointed out by the previous reviewer, the stability study was conducted in an incubator. In the revised manuscript, it is changed as stability chamber. This change of equipment seems to be surreal.

#2. The chromatograms looks like edited figures. Authors need to send original chromatogram for review.

#3. There is contradiction in the statements given under abstract section and in the methodology that, in the abstract authors state that four SiP solutions coded T1, T2, T3 and T4 were prepared by the authors, while in the methodology, authors state that the formulae were prepared and evaluated by a separate formulator. These statements are contradicting and confusing to the reader.

#4. As pointed out by the previous reviewer, the analytical method validation section is not satisfactory even after revision with respect to the procedure and the results reported.

#5. The usage of English language throughout the manuscript is to the standard mandated for a research article and need major editing.

Other observations:

#1. Line 2: Change Diabetic Mellitus to Diabetes mellitus.

#2. Line 32: Change stability chambers to stability conditions.

#3. Authors have mentioned in the abstract, 'The obtained solution (T4)........' T4 is one among the four solutions prepared and has not been obtained separately. Need to change the sentence accordingly.

#4. Line 42: “This study provides a solution….” should be revised meaningfully.

#5. The chemical name “3-amino-1-(3-trifluoromethyl)-6,8-dihydro-5H-(1,2,4) triazolo[4,3-a] pyrazin-7-y]- 4-(2,4,5-trifluorophenyl) butane-1-phosphoric acid hydrate]” Should be corrected by changing pyrazine-7-y to pyrazine-7-yl.

#6. Line 85: remove the semicolon.

#7. Under the heading ‘Instruments and Chromatographic conditions”, chromatographic conditions are not mentioned.

#8. Procedure for preparation of the formulae should be re-written in the sentence format, and not as bulleted points.

#9. Under the heading “ Quality control of the oral solution” authors state that the best formula was selected based on the organoleptic properties by the formulator (who is different from the author). If so, why authors are again unnecessarily describing about other formulae. Discussion on T, T2, T3, and T4 become unnecessary since authors have not formulated but have only carried out the stability studies.

#10. Under the heading, “Chemical analysis”, authors state that the amount of SiP in obtained solutions were investigated. If authors have already selected T4 for further evaluation based on organoleptic properties, which are the other solutions???

#11. Line 134: Column dimensions should be written in a standard format. What authors mean by “Pours” ????

#12. Line 135: Word “optimum” is not necessary.

#13. There is inconsistency in writing mL or ml. Please follow the journal format.

#14. Paragraph describing HPLC method development need revision. Mobile phase ratio should be represented in a generally used format. Column oven temperature is an important parameter, but is not reported. Total run time and Rt of analyte also needs mention.

#15. Line 142: Weights were measured…. This part should be placed in materials section.

#16. Analytical method validation section needs revision in terms of correct procedure and proper usage of English language. Why precision study is done on a concentration of 0.1285 mg/mL? How the range was calculated? What is the LLOQ and LOQ of the method?

#17. The title “Preparation of Stock, Sample and Standard solutions” are confusing. Is there any separate stock solution and standard solution? What is the concentration of standard stock solution? What would be the expected concentration in the final diluted sample solution should be mentioned.

# 18. In Table 2, related substances are specified as decimal points. What it represents? There is inconsistency in the usage of capital letters. For example: Complies.

#19. There is inconsistency in the text for “Table”

#20. Table 4 is incomplete in many respects. Results are not represented as required by the guideline. Authors have provided the results of validation in 3 tables. This should be comprehended and made a single concise Table.

#21. There is inconsistency in representing the retention time. Some place it is represented with 3 significant figures and in another place in two.

#21. Number of theoretical plates is represented as 4222 in Table 5, while in the text it is mentioned as 930 ±1

#22. Procedure for forced degradation study should be mentioned in the text and the chromatogram for the stability indicating assay method should be cited in the results.

**********

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 #3: 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.

PONE-D-20-27192R2

Stability of extemporaneously prepared Sitagliptin Phosphate Solution

PLOS ONE

Dear Dr. Zaid,

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.

==============================

Based on the reviewer comment,the manuscript still need some major revision.

==============================

Please submit your revised manuscript by Jun 18 2021 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:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled '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: http://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,

Girish Sailor

Academic Editor

PLOS ONE

[Note: HTML markup is below. Please do not edit.]

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 #4: All comments have been addressed

Reviewer #5: (No Response)

**********

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 #4: Yes

Reviewer #5: Partly

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #4: Yes

Reviewer #5: 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 #4: Yes

Reviewer #5: No

**********

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 #4: Yes

Reviewer #5: No

**********

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 #4: (No Response)

Reviewer #5: Dear author,

its a wild thought to produce a liquid oral preparation for the Sitagliptin. it could have been a better research article if you do your literature review in a proper way. I appreciate your effort with a strong disagreement. you never think about the hypoglycemic effect of the sorbitol and mannitol. hypoglycemia is a major side effect of OHGAs and Insulin. if mannitol and sorbitol has Hypoglycemic effect then how you can incorporate these polyhydroxy artificial sweeteners with a hypoglycemic drug. please read the reviewer comments attached.

**********

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 #4: No

Reviewer #5: 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.

Attachments

Attachment

Submitted filename: PLOS review.docx

PONE-D-20-27192R3Stability of extemporaneously prepared Sitagliptin Phosphate SolutionPLOS ONE

Dear Dr. Zaid,

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.

==============================All the comment was answered but still the manuscript required minor correction before publication which is attached.

==============================

Please submit your revised manuscript by Dec 10 2021 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:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled '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,

Girish Sailor

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

[Note: HTML markup is below. Please do not edit.]

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 #5: 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 #5: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #5: 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 #5: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #5: Yes

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Reviewer #5: (No Response)

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Reviewer #5: No

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Attachments

Attachment

Submitted filename: To PLOS.docx

Stability of extemporaneously prepared Sitagliptin Phosphate Solution

PONE-D-20-27192R4

Dear Dr. Zaid,

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.

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Kind regards,

Girish Sailor

Academic Editor

PLOS ONE

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