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 stagnant 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 a complementary shape and charge.[5] It relies on computer modeling techniques and bioinformatics approaches. Computational methods frequently serve to improve the affinity, selectivity, stability, and efficacy/potency of the drug with its target molecule. There are multiple steps before marketing a drug, including 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, and devices need to be safe as well.[8] Before starting human trials, formulations must successfully pass various studies of preclinical (animal) trials to ensure 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 formulations 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 is 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 healthcare is also crucial in ensuring the 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 a contributory role in the improvement of drug compliance. It is possible by sharing knowledge, and information, open communication, and collaborative decision-making. Good communication among all the above healthcare 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]

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References

1.

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: PMC4970633] [PubMed: 27528802]

2.

Seddon G, Lounnas V, McGuire R, van den Bergh T, Bywater RP, Oliveira L, Vriend G. Drug design for ever, from hype to hope. J Comput Aided Mol Des. 2012 Jan;26(1):137-50. [PMC free article: PMC3268973] [PubMed: 22252446]

3.

Snell ES, Griffin JP. How many medicines are there? Br Med J (Clin Res Ed). 1985 Mar 09;290(6470):773-4. [PMC free article: PMC1418536] [PubMed: 3918749]

4.

Munos B. Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov. 2009 Dec;8(12):959-68. [PubMed: 19949401]

5.

Zhou SF, Zhong WZ. Drug Design and Discovery: Principles and Applications. Molecules. 2017 Feb 13;22(2) [PMC free article: PMC6155886] [PubMed: 28208821]

6.

Yang Y, Ye Z, Su Y, Zhao Q, Li X, Ouyang D. Deep learning for in vitro prediction of pharmaceutical formulations. Acta Pharm Sin B. 2019 Jan;9(1):177-185. [PMC free article: PMC6362259] [PubMed: 30766789]

7.

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 Discov Today. 2017 Aug;22(8):1201-1208. [PubMed: 28627386]

8.

Thabet Y, Klingmann V, Breitkreutz J. Drug Formulations: Standards and Novel Strategies for Drug Administration in Pediatrics. J Clin Pharmacol. 2018 Oct;58 Suppl 10:S26-S35. [PubMed: 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. [PMC free article: PMC4179661] [PubMed: 24920522]

10.

Hixson-Wallace JA, Dotson JB, Blakey SA. Effect of regimen complexity on patient satisfaction and compliance with warfarin therapy. Clin Appl Thromb Hemost. 2001 Jan;7(1):33-7. [PubMed: 11190902]

11.

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

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. Psychiatr Serv. 2009 Mar;60(3):337-43. [PMC free article: PMC2710876] [PubMed: 19252046]

13.

Shikiar R, Rentz AM. Satisfaction with medication: an overview of conceptual, methodologic, and regulatory issues. Value Health. 2004 Mar-Apr;7(2):204-15. [PubMed: 15164810]

14.

Cropp CD, Beall J, Buckner E, Wallis F, Barron A. Interprofessional Pharmacokinetics Simulation: Pharmacy and Nursing Students' Perceptions. Pharmacy (Basel). 2018 Jul 20;6(3) [PMC free article: PMC6163764] [PubMed: 30036982]

Disclosure: Shanta Afrin declares no relevant financial relationships with ineligible companies.

Disclosure: Vikas Gupta declares no relevant financial relationships with ineligible companies.