Author(s): Ashok B. Patel, Avadhi R. Bundheliya, Rushali V. Zala, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth

Email(s): rushalizala285@gmail.com , sunnyrshsh@gmail.com

DOI: 10.52711/2231-5675.2022.00023   

Address: Ashok B. Patel1, Avadhi R. Bundheliya1, Rushali V. Zala1*, Amitkumar J. Vyas1, Nilesh K. Patel1, Ajay I. Patel1, Devang B. Sheth2
1B.K. Mody Government Pharmacy College, Rajkot- 360003, Gujarat, India.
2L.M. College of Pharmacy, Ahmedabad.
*Corresponding Author

Published In:   Volume - 12,      Issue - 2,     Year - 2022


ABSTRACT:
Dissolution testing is a critical methodology; widely utilized in the development of a new pharmaceutical product. The test, in its simplest form, consists of placing the formulation in a dissolution apparatus containing suitable dissolution medium. The BCS has been a predictive tool for assess the prospective effects of formulation on the human, drug oral bioavailability. When used in combination with in vitro dissolution tests, the BCS can maintain the prediction of in vivo product performance and the development. Filtration is critical in drug dissolution testing as filtration stops the dissolution process and allows for accurate quantitation through separation of dissolved and un-dissolved components. The objective of this investigation was to determine if other sinker shapes will influence the rate, extent, or variability of dissolution. Dissolution test is required to study the drug release from the dosage form and its in vivo performance. Dissolution test is used to asses the lot-to-lot quality of drug product. development and validation of dissolution procedure(s) and to provide practical approaches for determining specificity, linearity, range, accuracy, precision, LOD, LOQ and robustness of methods.


Cite this article:
Ashok B. Patel, Avadhi R. Bundheliya, Rushali V. Zala, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth. A Brief Review on Dissolution Method Development. Asian Journal of Pharmaceutical Analysis. 2022; 12(2):127-4. doi: 10.52711/2231-5675.2022.00023

Cite(Electronic):
Ashok B. Patel, Avadhi R. Bundheliya, Rushali V. Zala, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth. A Brief Review on Dissolution Method Development. Asian Journal of Pharmaceutical Analysis. 2022; 12(2):127-4. doi: 10.52711/2231-5675.2022.00023   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-2-11


REFERENCE:
1.    Mehdi H.M., Mizanur R.M., et al. A key approach on the dissolution of pharmaceutical dosage forms. J. Pharma Innovation, 2017, 6(9), 168-180.
2.    Priyanka M. Salve, Shital V. Sonawane, Mayuri B. Patil, Rajendra K. Surawase. Dissolution and Dissolution Test Apparatus: A Review. Asian Journal of Research in Pharmaceutical Sciences. 2021; 11(3):229-6. doi: 10.52711/2231-5659.2021.00037
3.    Reddy, K., et al. Pharmaceutical Excipients-Their Mechanisms. Research Journal of Pharmaceutical Dosage Forms and Technology 5.6 (2013): 355-360.
4.    Remington. The Science and Practice of Pharmacy. 19th Edition, Mack Publishing Company, 1995, volume-1, pp 680- 681.
5.    Dissolution studies Factor affecting dissolution and invitro-invivo Correlation. September 2021, https://www.slideshare.net/YogeshChaudhari46/dissolution-studydissolution-studies-factor-affecting-dissolution-and-invitro-invivo-correlation  
6.    Brahmankar D.M., Jaiswal S.B. Biopharmaceutics and Pharmacokinetics-A Treatise. Vallabh Prakashan, 2nd Edition, 2009, pp. 15-48.
7.    Subrahmanyam C.V.S. 2000. Text book of Physical Pharmaceutics. Vallabh Prakashan, 2nd Edition, 2000, pp. 85-105.
8.    Theories of Dissolution. October 2021, https://www.slideshare.net/Prashantdeore1/presentation-2-1-44770591
9.    Selection of Dissolution Media. September 2021, http://www.slideshare.net/sagarsavale1/dissolution-selection-of-dissolution-media?from_m_app=android
10.    Dissolution method Development. September 2021., http://www.slideshare.net/ArshadKhan63/dissolution-chapter?from_m_app=android
11.    US Pharmacopoeia, NF 41, The United State Pharmacopoeials Convention Inc, Rockville, 2016, pp 700.
12.    Ajay K.S., Ram S.B., et al. Biopharmaceutical Classification System: Tool base prediction for drug dosage formulation”. Advance Pharmaceutical Journal, 2017, 2(6), 204-209.
13.    Saxena, Swati, and Sarang Jain. A review on biopharmaceutical classification system. Asian Journal of Pharmacy and Technology 9.4 (2019).
14.    Anshu Sharma, CP Jain, MS Ashawat. Biopharmaceutics Classification System (BCS) and Biowaivers: Role in Drug Product Design. Research J. Pharm. and Tech. 1(3): July-Sept. 2008; Page 144-151.)
15.    Deshmane, S. V., et al. The Biopharmaceutics Classification System: A Review. Research Journal of Pharmacy and Technology 2.1 (2009): 8-11.
16.    Shah, A. M., Shah, S. R., Potdar, A., and Patel, V. Dissolution Enhancement-Nanonization: A Dissolution Enhancement Approach for BCS Class II Drugs)   
17.    Chavda VP, Soniwala M. Biological classification system (BCS); with a new perspective. MOJ Bioequiv Availab. 2017;3(4):108-109.)
18.    Kadam, S. V., D. M. Shinkar, and R. B. Saudagar. Review on solubility enhancement techniques.  IJPBS 3.3 (2013): 462-475.
19.    The Biopharmaceutical Classification, August 2021., https://slideplayer.com/slide/13031117/
20.    Basic approach Dissolution Method Development – Challenges and Regulatory Issues. August 2021, https://www.slideshare.net/HarshalPawar1/basic-approach-to-dissolution-method-development-challenges-and-regulatory-issues
21.    Dissolution Media. August 2021, http://www.slideshare.net/MeghrajSuryawanshi/seminar-on-dissolution-media?from_m_app=android
22.    Manju Nagpal, Pankaj Rakha, Surinder Goyal, Gitika Dhingra, Sunil Gupta. Comparison of Biorelevant and Compendial Dissolution Media and Prediction of In-vivo Plasma Profile of BCS Class II Drug. Research J. Pharma. Dosage Forms and Tech. 2010; 2(1):37-40.
23.    Dissolution procedure Development and validation changes to USP General Information Chapter 1092. October 2021., https://www.slideshare.net/shettyuc/dissolution-33496242
24.    B. Deepika., Rajan K., et al. Dissolution: a predictive tool for conventional and novel dosage forms. J. of Pharma Research., J Pharma Res, 2018, 7(6)., 113-119.
25.    Bhavesh V, Rajan K., et al. Development and validation of dissolution procedures. J. of Applied Pharmaceutical Science 01 (03), 2011, 50-56.
26.    Junaid J. Types of Sinkers and their effects in Dissolution Testing Aooaratus 1 and 2., September 2021., https://www.linkedin.com/pulse/types-sinkers-effects-dissolution-testing-apparatus-1-junaid-javed
27.    Hema RG. GC Gudeline. Int. Res. J. Pharm. Bio sci. 2017,4(3),41-50
28.    Ken B. What is USP’s Q value? August 2021, https://www.linkedin.com/pulse/what-usps-q-value-ken-boda
29.    Enzymes in the Dissolution Testing of Gelatin Capsules. August 2021., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4245433/#:~:text=possible%20(18).-, Pepsin,a%20pH%20less%20than%206.8.&text=Pepsin%20is%20a%20very%20stable,autohydrolysis%20is%20negligible%20(21).
30.    Radhakrishnan, G. Sampling in Mixed Methods Research. International Journal of Advances in Nursing Management 2.1 (2014): 24-27
31.    Analytical method validation for dissolution. September 2021, https://www.slideshare.net/BhanuAnalytical/dissolutionmethod-validation-pptslide-55147792
32.    Nikam, Seema R., et al. Bioanalysis-Method Development, Validation, Sample Preparation, its Detection Techniques and its Application. Asian Journal of Pharmaceutical Analysis. 11.4 (2021).
33.    Sahoo, C. K., et al. Validation of Analytical Methods: A Review. Int J Chromatogr Sep Tech: IJCST-112. DOI 10 (2018)
34.    Garcia, Pedro Lopez, et al. Analytical Method Validation. Wide spectra of Quality control 2 (2011): 3-21.
35.    Patil, Sunila T., Rajesh A. Ahirrao, and Sunil P. Pawar. A short review on method validation. Journal of Pharmaceutical and BioSciences. Oct Dec 5.4 (2017).
36.    Mujoriya, Rajesh Z. Analytical method development and validation of pharmaceutical technology: an overview. Research Journal of Pharmaceutical Dosage Forms and Technology. 5.4 (2013): 21-3-220.

Recomonded Articles:

Author(s): Sushil D. Patil, Sunil V. Amurutkar, C.D. Upasani

DOI: 10.5958/2231-5675.2016.00030.2         Access: Open Access Read More

Author(s): Dipti G. Phadtare, Pawar Amol R, R.B. Saudagar

DOI: 10.5958/2231-5675.2016.00019.3         Access: Closed Access Read More

Author(s): Pankaj Bhamare, Rupal Dubey, Neeraj Upmanyu, Pothuvan Umadoss

DOI: 10.5958/2231-5675.2021.00001.6         Access: Open Access Read More

Author(s): Hamid Khan, Javed Ali

DOI: 10.5958/2231-5675.2017.00020.5         Access: Open Access Read More

Author(s): K. Pramod, Shahid H. Ansari, Javed Ali

DOI:         Access: Open Access Read More

Author(s): G. Krishnamoorthy, C. Diana Priyadarshini, R. Senthamarai

DOI:         Access: Open Access Read More

Author(s): Shobha Rani G, Lohita M, Jaya Preethi P, Madhavi R, Sunisitha B, Mounika D

DOI:         Access: Open Access Read More

Author(s): Sushil D. Patil, Sayali K. Chaure, Maswood Ahmed Hafizur Rahman, Prajkta U. Varpe, Sanjay Kshirsagar.

DOI: 10.5958/2231-5675.2017.00004.7         Access: Open Access Read More

Author(s): Yogita R. Indalkar, Aloorkar N.H.

DOI: 10.5958/2231-5675.2015.00028.9         Access: Open Access Read More

Author(s): Pinaz A. Kasad, K.S. Muralikrishna

DOI:         Access: Open Access Read More

Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 


Recent Articles




Tags