Pharmaceutical Formulation


Definition/Introduction

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. Benefits and constraints of the active pharmaceutical ingredients (APIs), valuable excipients, associated interactions, and manufacturing procedure are the four basic components for a successful pharmaceutical formulation. The formulation often functions in a way that includes different dosage forms. The dosage form is the pharmaceutical drug product as marketed for use with a specific mixture of active ingredients and inactive components. It has to be a particular configuration(capsule shell, for example) and distributed into a particular dose. 

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] There are currently tens of thousands of medication formulations available on the market for clinicians to prescribe and for patients to utilize.[2][3] Each of these pharmaceutical formulations has had a significant amount of time and money put into the production to the combination of medications to understand how they work and to test their efficacy.[2] It is known that developed drugs interact with numerous proteins within the human body, and only a handful of these proteins are the targets of the medications developed; this leaves rooms for the future development of additional drugs to target the remaining proteins in the human body.[2][3]

Issues of Concern

With the significant amount of money invested annually, the list of medications aspires to grow each year.[1] However, the list stays stagnate annually as the amount of new molecular entities (NMEs) approved by the FDA annually does not increase by much because of the lack of certainty that is associated with drug design.[2][4] Drug design means, in general, the target molecule with which the drug will bind or want to interact must have the complementary shape and charge.[5] It relies on computer modeling techniques and bioinformatics approaches. Computational methods frequently serve to improve the affinity, selectivity, stability, efficacy/potency of the drug with its target molecule. There are multiple steps before marketing a drug that include the preclinical research on cell-based and animal models followed by the clinical trial on humans.[5] 

The development of pharmaceutical formulations is currently dependent on trial and error methods. Trial and error methods help predict optimal formulations. This process is time-consuming and expensive and involves a significant amount of labor to develop and monitor. There is pressure on the pharmaceutical industry to decrease the cost of healthcare and the number of new active pharmaceutical ingredients (APIs). To combat this, determining the desired formulations is necessary for the industry to determine efficient ways to develop drugs.[6][7]

API must be safe and efficacious, but the excipients, primary packaging materials, devices need to be safe as well.[8] Before starting human trials, formulations must successfully pass various studies of preclinical (animal) trials for ensuring safety and efficacy. Besides the knowledge of different formulation parameters, it is significant to understand the toxicology, pharmacokinetics, chemical, and physical characterization. When minimum physicochemical characterization is over, then the work for developing formulation begins.[9]

Clinical Significance

The clinical relevance of pharmaceutical formulation is that they have a significant impact on one’s quality of life, disease outcomes, and adherence to the treatment protocol. Additionally, the effectiveness of a pharmaceutical treatment depends on a multitude of factors, including a medication’s chemical properties, formulation, and mode of administration.[1] The drug must be stable and acceptable to the patient, and this is the primary consideration when developing a preparation. The drug form varies by route of administration, and identical drugs can produce different results depending on the route of administration. 

Developed medications have maximized efficiency when used properly. More complex regimens show decreased patient compliance; thus, it is necessary to develop a low complexity regimen for maximum effectiveness.[10][11][12]

Nursing, Allied Health, and Interprofessional Team Interventions

It is important to develop a formulation with a regimen that is not complex for a patient to follow to improve patient outcomes through adherence to developed pharmaceutical formulations.[10][11][12] Collectively, each component of the patient care team is associated with their satisfaction with care. More recently, there has been a focus on a patient’s satisfaction with their medication as a patient-reported outcome.[13] Developers need to determine a formulation route that is not a trial-and-error method, but more specialized to decrease labor and cost that is associated with the trial-and-error method and increase patient adherence to their regimens.[1][2][3][4] 

Not only is patient compliance essential, but the collaboration of all healthcare professionals involved in health care is also crucial in ensuring proper implementation of pharmaceutical formulations. The physician has to understand why and how the medication interacts with the human body. It is also imperative that nurses, pharmacists, and other essential team members maintain good communication and display accountability in administering medications to ensure patient safety.

Nursing, Allied Health, and Interprofessional Team Monitoring

All the health workers, including the nurse, allied health worker, and the interprofessional team, have the contributory role for the improvement of drug compliance. It is possible by sharing knowledge, information, open communication, and collaborative decision making. Good communication among all the above health care professionals can lead to better patient compliance and provide the perfect and optimal dosing by using the population and patient-specific pharmacokinetic parameters, thereby promoting medication safety through interprofessional collaboration in patient-centered care.[14] 

Correlation among the pharmacokinetics of the drug with the medical diagnosis, physical parameters, and laboratory findings can give the original information about the effectivity and compliance of the drug.[14]


Details

Author

Shanta Afrin

Editor:

Vikas Gupta

Updated:

6/20/2023 10:24:22 PM

References


[1]

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Seddon G, Lounnas V, McGuire R, van den Bergh T, Bywater RP, Oliveira L, Vriend G. Drug design for ever, from hype to hope. Journal of computer-aided molecular design. 2012 Jan:26(1):137-50. doi: 10.1007/s10822-011-9519-9. Epub 2012 Jan 18     [PubMed PMID: 22252446]


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Snell ES, Griffin JP. How many medicines are there? British medical journal (Clinical research ed.). 1985 Mar 9:290(6470):773-4     [PubMed PMID: 3918749]


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Munos B. Lessons from 60 years of pharmaceutical innovation. Nature reviews. Drug discovery. 2009 Dec:8(12):959-68. doi: 10.1038/nrd2961. Epub     [PubMed PMID: 19949401]


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Zhou SF, Zhong WZ. Drug Design and Discovery: Principles and Applications. Molecules (Basel, Switzerland). 2017 Feb 13:22(2):. doi: 10.3390/molecules22020279. Epub 2017 Feb 13     [PubMed PMID: 28208821]


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Yang Y, Ye Z, Su Y, Zhao Q, Li X, Ouyang D. Deep learning for in vitro prediction of pharmaceutical formulations. Acta pharmaceutica Sinica. B. 2019 Jan:9(1):177-185. doi: 10.1016/j.apsb.2018.09.010. Epub 2018 Sep 28     [PubMed PMID: 30766789]


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Zhang W, Zhao Q, Deng J, Hu Y, Wang Y, Ouyang D. Big data analysis of global advances in pharmaceutics and drug delivery 1980-2014. Drug discovery today. 2017 Aug:22(8):1201-1208. doi: 10.1016/j.drudis.2017.05.012. Epub 2017 Jun 13     [PubMed PMID: 28627386]

Level 3 (low-level) evidence

[8]

Thabet Y, Klingmann V, Breitkreutz J. Drug Formulations: Standards and Novel Strategies for Drug Administration in Pediatrics. Journal of clinical pharmacology. 2018 Oct:58 Suppl 10():S26-S35. doi: 10.1002/jcph.1138. Epub     [PubMed PMID: 30248193]


[9]

Shah SM, Jain AS, Kaushik R, Nagarsenker MS, Nerurkar MJ. Preclinical formulations: insight, strategies, and practical considerations. AAPS PharmSciTech. 2014 Oct:15(5):1307-23. doi: 10.1208/s12249-014-0156-1. Epub 2014 Jun 12     [PubMed PMID: 24920522]


[10]

Hixson-Wallace JA, Dotson JB, Blakey SA. Effect of regimen complexity on patient satisfaction and compliance with warfarin therapy. Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2001 Jan:7(1):33-7     [PubMed PMID: 11190902]


[11]

Morris LS, Schulz RM. Medication compliance: the patient's perspective. Clinical therapeutics. 1993 May-Jun:15(3):593-606     [PubMed PMID: 8364951]

Level 3 (low-level) evidence

[12]

Raue PJ, Schulberg HC, Heo M, Klimstra S, Bruce ML. Patients' depression treatment preferences and initiation, adherence, and outcome: a randomized primary care study. Psychiatric services (Washington, D.C.). 2009 Mar:60(3):337-43     [PubMed PMID: 19252046]

Level 1 (high-level) evidence

[13]

Shikiar R, Rentz AM. Satisfaction with medication: an overview of conceptual, methodologic, and regulatory issues. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2004 Mar-Apr:7(2):204-15     [PubMed PMID: 15164810]

Level 3 (low-level) evidence

[14]

Cropp CD, Beall J, Buckner E, Wallis F, Barron A. Interprofessional Pharmacokinetics Simulation: Pharmacy and Nursing Students' Perceptions. Pharmacy (Basel, Switzerland). 2018 Jul 20:6(3):. doi: 10.3390/pharmacy6030070. Epub 2018 Jul 20     [PubMed PMID: 30036982]