Stabilization of the pharmaceutical finished dosages form by using various techniques
Abstract
The stabilization of pharmaceuticals means that the drug product is physically, chemically and microbiologically stable at the recommended storage condition throughout the predefined shelf life of the product. Pharmaceutical formulations irrespective of its physical states have been used for their efficacy and safety so for as its therapeutic activity is concern. Stability of dosage forms is the ability of drugs to remains unaffected by environmental condition viz. temperature, humidity and microbiological contamination. This research work is an attempt to stabilize the drug product at controlled room temperature for the drug product which is stable at refrigerated storage condition. Hence the aim of present study was development and stabilization of the drug product at room temperature. Investigation of alternate manufacturing processes for stabilization of the drug product at controlled room temperature was one of the objectives of the work.
Keywords: Stability, shelf life, lyophilization, freeze drying
Keywords:
Stability, shelf life, lyophilization, freeze dryingDOI
https://doi.org/10.22270/jddt.v14i6.6619References
USP. Temperature-sensitive packaging snapshot. 2015. [Accessed January 23, 2018]. Available at: https://solvers.ups.com/assets/UPS_temp_sensitive_packaging_snapshot_infographic.pdf.
Markarian J. Understanding risks in pharmaceutical shipping. [Accessed January 23, 2018];Pharmaceutical Technology. 2015 39(8):52–54.
Tennermann J. Cold chain for beginners. Vaisala; Jun 20, 2012. [Accessed January 23, 2018]. Available at: www.pharmpro.com/article/2012/06/cold-chain-beginners.
Baxter International, Inc. Baxter initiates voluntary nationwide recall of one shipment of Intralipid 20% IV fat emulsion due to product being exposed to subfreezing temperatures. Oct 5, 2017. [Accessed January 23, 2018]. Available at: www.baxter.com/news-media/newsroom/press-releases/2017/10-05-17-intralipid-recall.page
Q1A(R2): Stability Testing Of New Drug Substances and Products.
Timothy J., Snape., Alison M., Astles., and Janice Davies., ‘Understanding the chemical basis of drug stability and degradation’ The Pharmaceutical Journal, Vol. 285, p416.
Panda BP, Patnaik S and Maharana RL. Trends in Design and Development of Nanopharmaceutical Dosage Forms. Bioequivalence & Bioavailability International Journal.1,1:2017. https://doi.org/10.23880/BEBA-16000104
Adepu S, Ramakrishna S. Controlled Drug Delivery Systems: Current Status and Future Directions. Molecules. 2021 Sep 29;26(19):5905. https://doi.org/10.3390/molecules26195905
Waterman KC, Adami RC, Alsante KM, Hong J, Landis MS, Lombardo F, Roberts CJ, Pfizer Global Research and Development, Eastern Point Road,Groton, CT 06340
Dave P., The Role of Pharmacists in Opioid Addiction Management. Asian Journal of Dental and Health Sciences, 2024;4(1):51–56. https://doi.org/10.22270/ajdhs.v4i1.71
Xiaolin (Charlie) Tang and Michael J. Pikal. Design of Freeze-Drying Processes for Pharmaceuticals: Practical Advice Pharmaceutical Research, 21;2: 2004. https://doi.org/10.1023/B:PHAM.0000016234.73023.75
PMid:15032301
Zimmermann CM, Baldassi D, Chan K, Adams NBP, Neumann A, Porras-Gonzalez DL, Wei X, Kneidinger N, Stoleriu MG, Burgstaller G, Witzigmann D, Luciani P, Merkel OM. Spray drying siRNA-lipid nanoparticles for dry powder pulmonary delivery. J Control Release. 2022 Nov;351:137-150. https://doi.org/10.1016/j.jconrel.2022.09.021
PMid:36126785 PMCid:PMC7613708
Gatto MS, Najahi-Missaoui W. Lyophilization of Nanoparticles, Does It Really Work? Overview of the Current Status and Challenges. Int J Mol Sci. 2023 Sep 13;24(18):14041. https://doi.org/10.3390/ijms241814041
PMid:37762348 PMCid:PMC10530935
Published
Abstract Display: 166 
PDF Downloads: 146 PDF Downloads: 13 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
How to Cite
.