Review: Formulation Development Studies

Abstract

The formulation development is crucial component of pharmaceutical development and important for therapeutic and commercial acquirement of product by delivering quality, safety and efficiency. The main parts of formulation development are product development methods like drug discovery, research etc. It is an essential factor not only in the starting stage of drug development, but also in later marketing success of drug product. It ties the exploration of a new drug substance to the successful development of a drug product. Formulation can determine patentability, lifecycle the success of a pharmaceutical product.

Introduction

I. PHARMACEUTICAL FORMULATION

Pharmaceutical formulation is the multistep process where the active drug is mixed with all other components by considering the factors of particle size, polymorphism, pH, and solubility and becomes the final beneficial medicinal product. Pharmaceutical formulation is the formation of a pharmaceutical product, including a drug's chemical properties, formulation, and details of the treatment protocol to be implemented in the clinical application [1, 2]

II. STEPS IN FORMULATIONS DEVELOPMENTS

A. Validation  and Characterization of Drug

The validation & characterization of drug is so much important because it affect the final product.

B. Drug Additive Compatibility Study

More the additive compatible with drug more the chances of drug formulation success and effect of drug is also increase.

C. Formulation Development

The next stage is formulation development in which chemicals goes with excipient and forms drugs.

D. Formulation Optimization

In this stage formulation like vaccine are produces this type of formulation have lots of studies than normal formulation and large amount of the knowledge needed

E. Formulation Assessment

The assessment studies help to enhance the already accomplished formulation by substitute the part of formulation like the solvent types

F. Stability Studies

It includes the stability of the formulation by performing tests so that the stability of formulation increase it also helps to improve the shelf life of formulation [3, 4 ,5].

III. PRE-FORMULATION STUDIES

Pre-formulation studies can defined as Laboratory studies to determine the characteristics of active substance and excipient that may influence formulation and process design and performance The pre-formulations is group of studies that emphasize the physicochemical properties of new drug candidate and combination with the excipient that affect drug performance.[6,7]

IV. OBJECTIVES

1. To develop the stable, effective and safer dosage form.
2. To provide useful information to design a new drug delivery system with better Bioavailability
3. To establish the physicochemical parameter of new drug.
4. To generate useful data needed in developing safe dosage forms that can be manufactured on a commercial scale.

Conclusion

The formulation development studies along with the pre-formulation studies include the various tests, research & the S.O.P handling. These are the important parameter of the pharmaceutical industries without this pharmaceutical industries does not conduct properly and the quality efficiency. New problems arise during development and it cannot be solve until required efforts with knowledge not met.

References

[1] https://www.ncbi.nlm.nih.gov/books/NBK562239/ [2] Stewart KD, Johnston JA, Matza LS, Curtis SE, Havel HA, Sweetana SA, Gelhorn HL. Preference for pharmaceutical formulation and treatment process attributes. Patient Prefer Adherence. 2016;10:1385-99. [PMC free article] [PubMed] [3] Industrial pharmacy i textbook by nirali by dr.ashok hajare page no.1.1to 1.40 [4] Preformulation Studies: An Integral Part of Formulation Design By Pinak Patel Submitted: July 16th 2018 Reviewed: December 3rd 2018 Published: June 9th 2019 DOI: 10.5772/intechopen .8 2868 [5] Various disintegration test dissolution test usp pharmacopeia stage 4 harmonization official may 1, 2020 ( 701-1 to 703-25) [6] PYROGEN TESTING Indian pharmacopeia 2007 volume-1 appendices -1British pharmacopeia 2007 Remington science and practise of pharmacy [7] Mundada AS, Meshram DR, Mishra M, Bhalekar MR, Avari JG. Formulation and evaluation of bitterless rapidly disintegrating tablet of Famotidine using ion exchange resins. Int J Pharm Excipients. 2008;7:23–5 [8] Shirsand SB, Suresh S, Para MS, Swamy PV, Kumar DN. Plantago ovata mucilage in the design of Fast disintegrating tablets. Indian J Pharm Sci. 2009; 71:41–5 [9] Loyd VA, Nicholas GP, Howard CA. Ansel’s pharmaceutical sosage forms and drug delivery systems. 8th ed. London: Lippincott Williams and Willkins; 2005. [10] Aulton ME, editor. Pharmaceutics, The science of dosage form design. 2nd ed. Sydney: Churchill livingstone; 2002. [11] McMillan A, Young H. The treatment of Pharyngeal Gonorrhea with a single oral dose of Cefixime. Int J STD AIDS. 2007;18:253–4 [12] Journal of Pharmaceutical Sciences Volume 74, Issue 1, January 1985, Pages 16-20 Research Articles Pre formulation Studies in a Drug Development Program for Tablet Formulations [13] Trevor M. Jones, CHAPTER 1:Preformulation Studies , in Pharmaceutical Formulation: The Science and Technology of Dosage Forms, 2018, pp. 1-41 DOI: [14] Sonali S Bharate &Ram A Vishwakarma impact of pre-formulation on drug development Pages 1239-1257 Published online: 27 Mar 2013 [15] An important approach for novel drug delivery system journal of biometric science polymer edition by hetesh kumar devangen 10.1080/09205063.2020.1825304 COOPER AND GUNNS DISPENSING FOR PHARMACEUTICAL STUDENTS 12ED (PB 2008

Copyright

Copyright © 2023 Satish Kumar Gupta, Richa Singh, Deepak Kumar Chaurasia, Dr. Tarkeshwar P. Shukla. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.