Author(s): Abhinaya N., Muddukrishna B.S., Ravindra Shenoy, Raveendra Pai, Girish Thunga, Sohil A. Khan, Girish Pai K.

Email(s): girish.pai@manipal.edu

DOI: 10.52711/0974-360X.2023.00562   

Address: Abhinaya N.1, Muddukrishna B.S.2, Ravindra Shenoy3, Raveendra Pai4, Girish Thunga5, Sohil A. Khan6, Girish Pai K.7*
1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education (MAHE), Manipal.
2Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education (MAHE), Manipal.
3Department of Commerce, Manipal Academy of Higher Education (MAHE), Manipal.
4Formulation Development, Glenmark Pharmaceuticals Limited M-4, Taloja MIDC, Taloja, Maharashtra, India.
5Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education (MAHE), Manipal.
6Pharmacotherapeutics and Evidence-Based Practice School of Pharmacy and Pharmacology, Griffith University 4222 Queensland, Australia.
7Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education (MAHE), Manipal.
*Corresponding Auth

Published In:   Volume - 16,      Issue - 7,     Year - 2023


ABSTRACT:
An ideal tablet should be of high quality and devoid of flaws. Tablet defects can lead to therapeutic failure and reduce the patient compliance in case of clinical perspective whereas it also imparts financial burden, loss of production time and reputation of the company. The research was carried out to investigate and find out the possible root causes of the broken tablet within the intact blister. Oral dosage forms were visually inspected in a hospital pharmacy in the Udupi district, using a validated checklist. A powdered uncoated Fluconazole tablet was found within the intact blister pocket of 1’s pack. A case study was formulated comprising of the dosage form, generic name, therapeutic category, probable root causes, defects, category of complaint, probable root causes and remediation and clinical significance. This unique outcome of the work can be used to train the health professionals which will further help them in avoiding such defects and defective products reaching the patients. Such defects can be bypassed by giving effective training to the staff using real-life case studies, taking corrective and preventive actions and conducting adequate in-process quality checks before releasing the products into the market. The use of such case studies will be effective in learning better and developing their skills in problem-solving and decision-making in ambiguous/complex situations.


Cite this article:
Abhinaya N., Muddukrishna B.S., Ravindra Shenoy, Raveendra Pai, Girish Thunga, Sohil A. Khan, Girish Pai K. A Systematic Investigation and Suggested Remedies for a Defective Marketed Solid Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(7):3399-4. doi: 10.52711/0974-360X.2023.00562

Cite(Electronic):
Abhinaya N., Muddukrishna B.S., Ravindra Shenoy, Raveendra Pai, Girish Thunga, Sohil A. Khan, Girish Pai K. A Systematic Investigation and Suggested Remedies for a Defective Marketed Solid Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(7):3399-4. doi: 10.52711/0974-360X.2023.00562   Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-7-59


REFERENCES:
1.    European Medicines Agency. Committee for Medicinal Products for Human Use. Reflection paper: formulations of choice for the paediatric population 2006; EMEA/CHMP/PEG/194810/2005. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf (accessed 8 August 2017).
2.    Sabri, Akmal H., et al. "Understanding tablet defects in commercial manufacture and transfer." Journal of Drug Delivery Science and Technology 46 (2018): 1-6.doi:https://doi.org/10.1016/j.jddst.2018.04.020
3.    Gaikwad SS, Kshirsagar SJ. Review on Tablet in Tablet techniques. Beni-Suef University Journal of Basic and Applied Sciences. 2020 Dec;9(1):1-7.doi:
4.    https://doi.org/10.1186/s43088-019-0027-7
5.    Rana AS, Kumar SH. Manufacturing defects of tablets-a review. Journal of Drug Delivery and Therapeutics. 2013;3(6):200-6. doi:https://doi.org/10.22270/jddt.v3i6.722
6.    Albert V, Lanz M, Imanidis G, et al. Stability of medicines after repackaging into multicompartment compliance aids: eight criteria for detection of visual alteration. Drugs & Therapy Perspectives. 2017 Oct;33(10):487-96.doi: 10.1007/s40267-017-0431-9
7.    SUN X. Research on customer complaints in the background of industry 4.0. Korea Journal of Artificial Intelligence. 2020;8(2):23-8.doi:: http://dx.doi.org/10.24225/kjai.2020.8.2.23
8.    World Health Organization. WHO Global Surveillance and Monitoring System for substandard and falsified medical products. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO. Available from: https://www.who.int/medicines/regulation/ssffc/publications/gsms-report-sf/en/Accessed 20 Apr 2020.
9.    FDA report: Drug quality tops OPQ's list of product defects. Available from: https://www.raps.org/news-and-articles/news-articles/2021/8/fda-report-drug-quality-tops-opqs-list-of-product.(Accessed 10 December 2022)
10.    1 in 10 medical products in developing countries is substandard or falsified.https://www.who.int/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified Available from: https://www.who.int/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified (Accessed on 12 December 2022)
11.    Možina M, Tomaževič D, Pernuš F, Likar B. Automated visual inspection of imprint quality of pharmaceutical tablets. Machine Vision and applications. 2013 Jan;24(1):63-73.doi: https://doi.org/10.1007/s00138-011-0366-4
12.    Yost E, Chalus P, Zhang S, Peter S, Narang AS. Quantitative X-ray microcomputed tomography assessment of internal tablet defects. Journal of Pharmaceutical Sciences. 2019 May 1;108(5):1818-30.doi: 10.1016/j.xphs.2018.12.024
13.    Taylor S, Glass BD. Altering dosage forms for older adults. Australian Prescriber. 2018 Dec;41(6):191.doi: 10.18773/austprescr.2018.063
14.    Meliones A, Baltas D, Kammenos P, Spinnler K, Kuleschow A et al. A distributed vision network for industrial packaging inspection. International Conference on High-Performance Computing and Networking 1999 Apr 12 (pp. 1303-1307). Springer, Berlin, Heidelberg.doi: 10.1007/BFb0100713
15.    Chavda R, Gohil D, Patel A, Hemnani S, Patel S, Patel MS. Detection of defect in pharma-tablets using image processing. International Journal of Computer Science and Information Technology Research. 2015;3:49-52.
16.    Reddy GR, Jahnavi TS, Rushali D, Kumar BA. Bliss bot for pharmaceutical inspection. In2017 International Conference on Trends in Electronics and Informatics (ICEI) 2017 May 11 (pp. 354-359). IEEE.
17.    Možina M, Tomaževič D, Pernuš F, Likar B. Automated visual inspection of imprint quality of pharmaceutical tablets. Machine Vision and Applications. 2013 Jan;24(1):63-73.doi: https://doi.org/10.1007/s00138-011-0366-4
18.    Schiavetti B, Wynendaele E, Melotte V, Van der Elst J, De Spiegeleer B, Ravinetto R. A simplified checklist for the visual inspection of finished pharmaceutical products: a way to empower frontline health workers in the fight against poor-quality medicines. Journal of pharmaceutical policy and practice. 2020 Dec;13(1):1-7.doi: 10.1186/s40545-020-00211-9
19.    Albert V, Lanz M, Imanidis G, Hersberger KE, Arnet I. Stability of medicines after repackaging into multicompartment compliance aids: eight criteria for detection of visual alteration. Drugs & Therapy Perspectives. 2017 Oct;33(10):487-96.doi: 10.1007/s40267-017-0431-9
20.    Abhinaya N, Thunga G, Muddukrishna BS, Pai R, Shenoy UR, Khan S, Pai KG.A Research on effective management of manufacturing defects to avoid product recalls: a challenge to pharmaceutical industry. Research Journal of Pharmacy and Technology. 2019 Dec 30;12(12):6124-32.doi: 10.5958/0974-360X.2019.01064.3
21.    Hemanth GK, Shenoy UR, Thunga G, Agrawal SK, Joshi M, Sathyanarayana MB, Tippavajhala VK, Abhinaya N, Kulyadi GP. Solid dosage forms: A detailed research on non-conforming product quality. Indian Journal of Pharmaceutical Education and Research. 2020 Jul 1;54(3):S473-84.doi: 10.5530/ijper.54.3s.146
22.    Hemanth KG, Joshi M, Dayaramani R, Damodharan N, Shenoy R, Girish PK. Pharmaceutical defects: A critical review on defects of various dosage forms and regulatory impacts. Research Journal of Pharmacy and Technology. 2020;13(9):4505-8.doi:10.5958/0974-360X.2020.00794.5
23.    Albion K, Briens L, Briens C, Berruti F. Detection of the breakage of pharmaceutical tablets in pneumatic transport. International Journal of Pharmaceutics. 2006 Sep 28;322(1-2):119-29.doi: 10.1016/j.ijpharm.2006.05.039
24.    Bogda MJ. Tablet compression: Machine theory, design and process troubleshooting. Encyclopedia of Pharmaceutical Technology. 2002;2:2669-88.
25.    Shangraw RF. Compressed tablets by direct compression. Pharmaceutical dosage forms: Tablets. 1989 Jun 5;1:195-246.
26.    Uzondu B, Leung LY, Mao C, Yang CY. A mechanistic study on tablet ejection force and its sensitivity to lubrication for pharmaceutical powders. International Journal of Pharmaceutics. 2018 May 30;543(1-2):234-44.doi:https://doi.org/10.1016/j.ijpharm.2018.03.064
27.    Natoli D. Tooling for pharmaceutical processing. In Pharmaceutical Dosage Forms-Tablets 2008 Jun 3 (pp. 17-64). CRC Press.
28.    Ensuring that the manufacturing process is controlled and all the products are checked for accuracy before the release. Available from: https://www.gmpsop.com/fundamentals-of-quality-control-practice-in-pharmaceuticals/((accessed on 15 december2022).
29.    Nayak A, Katta H, Thunga G, Pai R, Khan S, Kulyadi GP. A critical analysis of labeling errors of high-alert medications–Safety assessment and remedial measures through case based approach. Clinical Epidemiology and Global Health. 2022 Nov 1;18:10116.doi: 10.1016/j.cegh.2022.101161
30.    Lafeber I, Ruijgrok EJ, Guchelaar HJ, Schimmel KJ. 3D Printing of Pediatric Medication: The End of Bad Tasting Oral Liquids? —A Scoping Review. Pharmaceutics. 2022 Feb 14;14(2):416.doi: 10.3390/pharmaceutics14020416
31.    Seyedmousavi S, Rafati H, Ilkit M, Tolooe A, Hedayati MT, Verweij P. Systemic antifungal agents: current status and projected future developments. InHuman Fungal Pathogen Identification 2017 (pp. 107-139). Humana Press, New York, NY.doi: 10.1007/978-1-4939-6515-1_5
32.    Shrestha J, Shrestha A, Shrestha B, Gamal K, Manandhar S, Koju S, Shrestha RK. Oral Solid Dosage form Modification in Community Pharmacies of Kavrepalanchok and Bhaktapur Districts of Nepal. Kathmandu University Medical Journal. 2022 Mar 31;20(1):29-37.
33.    Lam WY, Fresco P. Medication adherence measures: an overview. BioMed research international. 2015 Oct 11;2015.doi: 10.1155/2015/217047
34.    Low CY, Rotstein C. Emerging fungal infections in immunocompromised patients. F1000 medicine reports. 2011;3. doi: 10.3410/M3-14
35.    Stubbs J, Haw C, Dickens G. Dose form modification–a common but potentially hazardous practice. A literature review and study of medication administration to older psychiatric inpatients. International psychogeriatrics. 2008 Jun;20(3):616-27.doi: 10.1017/S1041610207006047.
36.    Ambadipudi VG, Kulyadi GP, Tippavajhala VK. Advances in powder flow characterization by Freeman Technology using FT4 Powder Rheometer. Research Journal of Pharmacy and Technology. 2019;12(11):5536-42.doi: https://doi.org/10.5958/0974-360X.2019.00960.0
37.    Kumar V, Bhardwaj A, Singh N, Goyal K, Jindal S. A Review on Tablet Dosage Form: Recent Advancements with Special Emphasis on Rapid Disintegrating Tablet.doi: 10.52711/2231-5659.2021.00038  
38.    Krishna TV, Kumar L, Reddy MS, Rao R, Ankineedu M, Pai KG. Investigation to find out the root cause for presence of broken tablet in the marketed blister pack. Research Journal of Pharmacy and Technology. 2015; 8(6): 707-9.doi: 10.5958/0974-360X.2015.00112.2
39.    Fatima J, Sadiq SM, Ahmed S, Khan R, Uddin MN. Patient medication adherence and the health outcome. Asian Journal of Pharmaceutical Research. 2018; 8(2): 78-82. doi:10.5958/2231-5691.2018.00013.8   
40.    Chavhan AB, Bhoi DM. Pharmacovigillance: Drug Safety Monitoring. Asian Journal of Pharmacy and Technology. 2019; 9(1): 49-52. doi: 10.5958/2231-5713.2019.00009.6
41.    Abubakar AR, Simbak NB, Haque M. Adverse drug reactions: predisposing factors, modern classifications and causality assessment. Research Journal of Pharmacy and Technology. 2014; 7(9): 1091-8.
42.    Sawant A, Kamath S, Katta HG, Badamane SM, Shenoy R, Pai GK. Investigation of manufacturing defects and cGMP lessons learnt from quality issues in Pharmaceutical Sterile Preparations. Research Journal of Pharmacy and Technology. 2022; 15(2): 729-35. doi: 10.52711/0974-360X.2022.00121
43.    Biju BP, Stephen J, Benedict NM, Shani N, Panikar SS, Jacob AM. Effectiveness of Self-Instruction Module on knowledge regarding medication errors and its prevention among staff nurses at selected hospital, Kollam. International Journal of Nursing Education and Research. 2019; 7(1): 38-40. doi:10.5958/2454-2660.2019.00008.5
44.    Shewale BD, Patil PO, Kosalge SB, Fursule RA, Sapkal NP. Quality Education in Pharmacy: Need of 21st Century. Research Journal of Pharmacy and Technology. 2009;2(4):648-52.
45.    Zolezzi M, Abdallah O, Sankaralingam S. Development and evaluation of an educational program for community pharmacists on cardiovascular risk assessment. Risk Management and Healthcare Policy. 2020 Jun 22: 623-32 .doi:10.2147/ RMHP.S231075


Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank

Journal Policies & Information


Recent Articles




Tags


Not Available