FORMULATION AND EVALUATION OF AN INJECTABLE SOLUTION AS A DOSAGE FORM
Abstract
The present study will outline formulation and the evaluation methods of injectable dosage form. The various initial formulations of the developed and those are examined for drug release profile, bioavailability, and clinical effectiveness and for the pilot plant studies and production scale-up. The drug that we need should be most convenient and in proper form then only it reaches to the desired site of action. This is greatly influenced by which the type of dosage form of the drug. Since, injections include much variety of therapeutic agents. Injections are sterile, pyrogen limited, that is, bacterial endotoxin units limit, preparations intended to be administered parenterally. It is well recognized that the advantages of parenteral injections are immediate systemic drug availability and rapid onset of action.
Keywords: Injectable, Parenteral, Sterilization, Tonicity
Keywords:
Injectable, SterilizationDOI
https://doi.org/10.22270/jddt.v8i5.1854References
Gary Evans and David Spadling. Handbook of Bioanalysis and Drug Metabolism.2004, Chapter 1, Bioanalysis, Pharmacokinetics and drug metabolism (BPDM). P. 1
Drug Approvals and Databases, U.S Department of Health and Human Services, [internet]. 2017 [Updated 2017 Nov 14].
Available from: - https://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
Katdare A, Chaubal MV. Excipient development for pharmaceutical, biotechnology, and drug delivery systems. Taylor and Francis Group, LLC, 2006. Chapter 1; Regulation of pharmaceutical excipients. p. 37-38
Loyd V Allen, Jr., Nicholas G.popovich, Howard C. Ansel. Ansel’s Pharmaceutical dosage forms and drug delivery systems, 9th ed.Philadelphia: Lippincott Williams & Wilkins; 2011. Section II, Drug dosage form and drug delivery design, Chapter 4, Dosage form design: Pharmaceutical and formulation consideration. P.92
Dosage form designs [internet]. Available from : http://www.bspublications.net/downloads/05805bfacb3933_Ch-1_Pharmaceutical%20Dosage%20form_Kamlesh.pdf
Nagaraja Y.S., Nagaraja T.S., Bharathi D. R. and Manjunatha T. O. Formulation and evaluation of ofloxacin aqueous injection. IJPLS, 2012; 3(10):2015-2020
Venaktesawara Reddy B, Rasmitha Reddy B, Navaneetha K, Sampath Kumar V. A review on parenteral production technology. International journal of pharmacy and biological sciences. 2013; 3(1):596-610
Medical dictionary. The free dictionary by Farlex. [Internet]. 2013-2018. Available from: https://medical-dictionary.thefreedictionary.com/injection.
Gulati N, Gupta H. Parenteral drug delivery: a review. Recent patents on drug delivery & Formulation 2011, 5:133-145.
M.C. Allwood. Antimicrobial agents in single- and multi-dose Injections. Journal of Applied Bacteriology. 44(1), Svii- Sxvii. Willey online library.
Agrawal M, Limbachiya M, Sapariya A, Gatel G. A review on Prenteral controlled drug delivery system. International journal of Pharmaceutical Sciences and Research. P.3656-3669
Small volume parenterals. [Internet]. 2013-2018. Available from: https://pharmlabs.unc.edu/labs/parenterals/svp.htm
Large volume parenterals. [Internet]. Available from: http://pqri.org/wp-content/uploads/2015/11/Sacha.Characteristics_and_Requirements_for_Large_Volume_Parenterals.pdf
Joanne Broadhead, Pharmaceutical preformulation and formulation. Second edition. Volume 199, A practical guide from candidate drug selection to commercial dosage form, chapter 9: Parenteral dosage forms. P.332-350
Pramanick S, Sinodia D, Chandel V. Excipient selection in parenteral formulation development. Pharma Times. 2013; 45(3):65-75.
Michael J. Akers. Excipient- drug interactions in parenteral formulations. Journal of Pharmaceutical Sciences. 2002; 91(11):2283-2300.
Method used in the preparation of parenteral products. [Internet]. Available from: http://www.preservearticles.com/2011122319161/what-are-the-methods-used-in-the-preparation-of-parenteral-products.html
Linda A. Felton. Remington: Essentials of Pharmaceutics, Chapter 26, parenteral preparations. P. 497-530
General Pharmacology. Available from: file:///C:/Users/user/Downloads/Routes-of-adminstartion.pdf
What are the methods used in the preparation of parenteral products.[Internet]. Available from: http://www.preservearticles.com/2011122319161/what-are-the-methods-used-in-the-preparation-of-parenteral-products.html
Maquille A, Slegers C, Habib JL, Tilquin B. Electron beam and gamma radiolysis of solid-state metoclopramide. Pharm Res 2006; 23: 1343-1349.
Boyd C. E-beam sterilizes the industry. J Student Res 1.P. 39-43, 2002.
Marie- Noel Primeau MD, N.Franklin Adkinson Jr MD, Robert G. Hamilton PhD. Natural rubber Pharmaceutical vial closures release latex allergens that produce skin reactions. Journal of Allergy and Clinical Immunology. 2001; 107(6):958-962
pH from Wikipedia, the free encyclopedia. [Internet]. 2018[updated June 1] Available from: https://en.wikipedia.org/wiki/PH
Stephen E. Langille, Ph.D. Particulate matter in injectable drug. PDA journal of pharmaceutical Science and technology. 2018, July 7.p.1-17
FDA Guidelines 2004 “Guidance for Industry Sterile Drug Products by Aseptic processing, Current Good Manufacturing Practices,” September, 2004
ISO 11377 ANSI/AAMI/ISO 1137-2 1998-Sterilization of Medical Devices – Microbiological Methods- Part 2, Tests of sterility Performed in the Validation of a Sterilization Process
ISWO 11135 1994 Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
Code of Federal Regulations Title 21/Chapter 1/Part 820, “Quality systems Requirements: General ,” 2006
Guidance for Q1A (R2) stability testing of new drug substances and products under ICH guidelines
Published
Abstract Display: 8172
PDF Downloads: 8991 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).

.