Submited on: 06 Oct 2010 08:12:05 AM GMT
Published on: 06 Oct 2010 07:29:58 PM GMT
 

  • What are the main claims of the paper and how important are they?

    The main claims of the paper is that the polymer concentration and polymer blend ratio of HPMC K15M and Carbopol 934P impact the release profile of a direct compression Propranolol Hydrochloride controlled release tablet.

     

    These claims are not very important - as these effects are well known and expected for these polymer systems. However, the methodological approach utilizing statistical design of experiments is capable of providing detailed descriptions when executed appropriately.


  • Are these claims novel? If not, please specify papers that weaken the claims to the originality of this one.

    No, these claims are not novel. The authors note references 5,6,7,8, and 9 as studies of Carbopol and HPMC in controlling the release profile. Other examples below:

     

    Bertram U, Bernard MC, Haensier J, Maincent P, Bodmeier R. “In situ gelling nasal inserts for influenza vaccine delivery” Drug Development and Industrial Pharmacy 2010 May; 36(5):581-93

     

    Belgamwar V, Shah V, Surana SJ. “Formulation and evaluation of oral mucoadhesive multiparticulate system containing metoprolol tartarate: an in vitro - ex vivo characterizarion” Current Drug Delivery 2009 Jan; 6(1):113-21

     

    Yamsani W, Gannu R, KOlli C, Rao ME, Yamsani MR. “Development and in vitro evaluation of buccoadhesive carvedilol tablets” Acta Pharma 2007 Jun; 57(2):185-97

     

    Rahman Z, Ali M, Khar R. “Design and evaluation of bilayer floating tablets of captopril” Acta Pharma 2006 Mar; 56(1):49-57

     

    Bertram U, Bodmeier R. “In situ gelling, bioadhesive nasal inserts for extended drug delivery: In vitro characterization of a new nasal dosage form” European Journal of Pharmaceutical Sciences 2006 Jan; 27(1):62-71

     

    Kumar A, Agarwal SP,Khanna R. “Modified release bi-layered tablet of melatonin using beta-cyclodextrin” Pharmazie 2003 Sep; 58(9):642-4




  • Are the claims properly placed in the context of the previous literature?

    No, very little to no discussion is presented regarding placing the study results in context with previous literature.


    The value the authors appear to intend to provide a case study example of an experimental approach utilizing a full factorial statistical DOE of the 2 factors and 3 levels. Statistical DOE approaches are not novel and are commonly utilized in industrial practices, however, there is a need to encourage and expand the use of these techniques and so adds value to the community as an example of a structured approach to formulation design.

     

    However, given lack of novelty of claims and even the experimental approach, a full treatment and discussion regarding the decision making process and analysis should be included, which is sorely lacking in this article.


  • Do the results support the claims? If not, what other evidence is required?

    The results support the claims as stated - clearly polymer concentration and blend composition impacts the release rate, as is well known. Given the experimental approach, the claims could be much better substantiated and described by including presentation and discussion of the statistical analysis outcomes regarding the model parameters and active terms identified to best predict the release. Lack of this discussion is a substantial deficiency in the paper.


  • If a protocol is provided, for example for a randomized controlled trial, are there any important deviations from it? If so, have the authors explained adequately why the deviations occurred?

    Not applicable


  • Is the methodology valid? Does the paper offer enough details of its methodology that its experiments or its analyses could be reproduced?

    The paper does not provide enough details of either experimental methodology or statistical analysis to allow for reproduction.

     

    Materials used and their sources are not adequately defined or included. Methodology is extremely unclear - How were the formulations prepared - a conical blender (manufacturer and size?) or by hand in bags? Were the materials screened to prevent lumping and ensure adequate mixing? What were the compositions of the formulations - drug:filler:glidant proportions? What glidant and filler was used? What was the formulation batch size?

     

    What was the rotary press used? What was the press speed / tablet dwell time? What were the pre-compression and main compression forces utilized? Press feeder speed?

     

    These questions are a significant deficiency of the paper.


  • Would any other experiments or additional information improve the paper? How much better would the paper be if this extra work was done, and how difficult would such work be to do, or to provide?

    A full presentation and discussion of the statistical analysis and resulting outcomes are necessary. What were the effect sizes and confidence intervals of the significant terms? What was the significance cut off limit? What criteria was utilized to determine statistical model selection for prediction of release performance? What was the resulting model utilized? Were any significant interaction or non-linear terms identified?

     

    Discuss fully why the parameters of interest were chosen, why the upper and lower limits were chosen for each, why is nonlinearity expected, are there any expected synergistic or anti-synergistic behavior? Why was a full factorial design chosen? Response surface methodologies (RSM) are more appropriate for optimization studies which explicitly determine effect sizes and expected confidence intervals for reproducibility whereas factorial designs are best utilized for screening for activity of specific terms and parameters prior to optimization studies. As such, it is inappropriate to describe this study as an optimization study.

     

    A full discussion of completed work should not be much more work and would add significant value to the paper. However, to match the current title, a follow-up RSM optimization study would be best, in addition to updated methodology details.


  • Is this paper outstanding in its discipline? (For example, would you like to see this work presented in a seminar at your hospital or university? Do you feel these results need to be incorporated in your next general lecture on the subject?) If yes, what makes it outstanding? If not, why not?

    No, there are significant deficiencies in this paper. See previous comments for examples.


  • Other Comments:

    Overall, this paper needs to address some serious deficiencies noted previously. The intent of the work is fine, but the paper as presented is incomplete. Completing the open questions stated previous is necessary to bring value to the paper.

  • Competing interests:
    .
  • Invited by the author to review this article? :
    No
  • Have you previously published on this or a similar topic?:
    No
  • References:

    .

  • Experience and credentials in the specific area of science:

    I have 4+ years of industrial experience working as a scientist/engineer in oral solid dosage design and development. I executed multiple statistical DOE studies in formulation and process design during this time. I am now currently a graduate student enrolled in a PhD program in pharmaceutical sciences.

  • How to cite:  Defrese M K.Review of Optimization of of Propranolol Hydrochloride Controlled Release Matrix Tablet Using Factorial Design[Review of the article 'Optimization Of Propranolol Hydrochloride Controlled Release Matrix Tablet Using Factorial Design ' by Patel G].WebmedCentral 2011;7(11):WMCRW003347
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Optimization of propranolol HCl CR tablet
Posted by Mr. Rikesh Patel on 11 Feb 2011 11:26:39 AM GMT

1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? Yes
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? Yes
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? No
7 Can you suggest any reductions in the paper, or deletions of parts? No
8 Is the quality of the diction satisfactory? Yes
9 Are the illustrations and tables necessary and acceptable? Yes
10 Are the references adequate and are they all necessary? Yes
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments:

    This research article has enough strength to publish it.

  • Competing interests:
    No
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    Yes
  • References:
    None
  • Experience and credentials in the specific area of science:

    Presently I am working as a research associate in formulation and development department.

  • How to cite:  Patel R .Optimization of propranolol HCl CR tablet[Review of the article 'Optimization Of Propranolol Hydrochloride Controlled Release Matrix Tablet Using Factorial Design ' by Patel G].WebmedCentral 2011;2(2):WMCRW00456
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