Chapter 3 Methodology of the Oral Delivery of Therapeutic Proteins and Peptides Research

3.0 Methodology of the Oral Delivery of Therapeutic Proteins and Peptides Research

3.1 Theoretical framework

The current paper is based on two principles that guide the practice of pharmacology, including pharmacokinetics and pharmacodynamics. Each of these theories, rather principles and the ways in which they influence the current study are explained below.

3.1.1 Pharmacokinetics

This paper functions as a proposal for a study that will investigate the diverse pharmacological strategies to enhance the bioavailability of therapeutic protein and peptides in the gastrointestinal tract. The very nature of this research direction compels the researcher to consider the principle of pharmacokinetics, which involves the consideration of both patient-related elements and drugs chemical properties as elements that influence the fate of therapeutic substances (Hart & Ksir, 2011, p. 61). Pharmacokinetics otherwise abbreviated as PK, concerns substances of interest including toxins, nutrients, hormones and agents in a quest to explore the fate of medication from the time it gets administered until when the substance is eliminated from the body. The theory contends that the patient factors affect the drug upon its demonstration through the absorption and distribution mechanisms. Argued in the premise is that chemical transformations of the drug within the patients body (such as through metabolic enzymes and pH transformations), as well as the routes and effects of the drugs metabolite influence its fate (effectiveness, bioavailability, and outcomes). This theory is considered useful in the current study as it allows the researcher to look into the patient-related and drug-associated factors affecting the bioavailability of therapeutic proteins and peptides in the gastrointestinal tract. Using this theory as a standpoint for pharmacological studies allows the comprehensive investigation of ways in which the performance of a drug can be augmented through the manipulation of patient and drug factors (Mcclements & Decker, 2009, p.41). This theory finds further justification in Anderles (2009, p. 78) works where the author emphasizes the significance of studying drug pathways and absorption mechanisms in studies that aim at augmenting these function through patient-based (such as absorption enhancers) or drug-based (such as chemical modifications) initiatives.

3.1.2 Pharmacodynamics

Meanwhile, the pharmacodynamics presents an important theoretical framework for this study endeavour as it facilitates the consideration of the physiological and biochemical effects of medication on the patients body, the connection between the drug concentration and outcomes, as well as the mechanisms of drug action (Johnson & Byrne, 2003, p. 812). Although sometimes visualized as the exact opposite of pharmacokinetics, this theory can be used in conjunction with the farmers as the both aim at estimating the outcomes of drugs once they are ingested by the patient. Pharmacodynamics is highly relevant to this study as the bioavailability (which determines the concentration of the drugs within the systemic circulation) influences the performance of the drugs (Aluko, 2012, p. 67). Among the widespread illustrations of the relationship underlying the pharmacodynamics theory in the receptor drug interaction as modelled by the following equation:

Where R is the receptor (the site of attachment), L stands for the ligand (or drug). Development in this theory has allowed the study of this reaction dynamics in mathematical fashion through the deployment of apparatus including free energy maps. Pharmacodynamics is traditionally understood as the study of how the body influences the drug, and this is important in understating the role of changing pH, digestive juices and enzymes, and so forth on the bioavailability of therapeutic peptides and proteins (Fox, 2009, p. 6).

3.2 Research methods: systematic review

Researchers can use either primary or secondary data sources in their study endeavours. Primary sources are typically sourced from original experiences (through observations, questionnaires, interviews, and so forth), and this may entail conducting field activities in the quest for new or novel insight in the study phenomenon (Mcclements & Decker, 2009, p.41). Meanwhile, secondary sources entail published materials that provide important insight according to the study in question. Researchers can use systematic reviews, which entails the methodological investigation of what preliminary studies present in a quest to provide comprehensive answers to a particular research problem. This outcome is often attainable by paying keen attention to the findings and arguments of other researchers, which guarantees relevant and accurate conclusions based on the quality of evidence provided by each of the included articles. A literature-base study was deemed appropriate for this study bearing in mind the extensive works that have been done concerning the bioavailability of therapeutic peptides and proteins. The method will be used to the advantage of the current study as it involves minimal use of time and resources, which are among the most paramount problems with primary studies (Johnson & Byrne, 2003, p. 812).

3.3 Multiple search strategies

When conducting a literature review, it is paramount that the researcher is able to yield the most comprehensive number of articles that can be sourced from the search of the literature. The quality of a literature review type of research is highly dependent on the number and quality of articles that are obtained from the search literature pieces (Krishna & Yu, 2007, p. 11). As such, it is paramount that a researcher uses varied methods to search for the articles to be included in the literature review. For example, the researcher needs to search from different databases, use different combinations of terms and filter the articles obtained in a thorough manner to ensure that quality articles are obtained for the research.

3.4 Selection procedure

Phrases such as bioavailability of protein drugs, bioavailability of therapeutic proteins, mechanisms affecting the absorption of drugs in in the gastrointestinal tract, strategies to enhance the bioavailability of protein and peptide drugs will be used because of their relevance to the three research questions of this study. These research terms were deemed justifiable bearing in mind their open structure, which guaranteed a rich yield of articles dealing with the relationship between health practitioners preparedness and their ability to help trauma patients experience health improvements (Whitney & Rolfes, 2011, p. 27).

Worth mentioning is that the selection criteria will include four distinct stages. The first stage will involve selecting articles based on the information that existed in their titles. This stage will come before the next step where the researcher read the abstract section of selected articles to find, after which those that included irrelevant information will be excluded. The third stage, typically aiming at reducing the number of selected articles, will involve evaluating the connection between introduction and results section of the selected papers and the researched questions of the proposed study. Upon eliminating all studies that do not respond to my research questions, the articles will be chosen based on the language of publication (only those published in English were included) and their focus on methods of improving the bioavailability of therapeutic peptides and proteins. Among the databases that will be used to select the one hundred and sixteen articles that are reviewed in this study include Pub Med, Ovid, EBSCO, Cochran, APA Psyc Net, and Oria.

3.5 Methods of analysis

Data describing qualitative studies and randomized control trials and the quality of studies gained through database searches (and authors) will be combined in a narrative synthesis of results. A statistical method (meta-analysis) would be used to integrate findings from diverse studies after which a general summary will be approximated according to the weight value of each study (based on their sample size) (Gaginella, Mozsik, & Rainsford, 2007, p. 78). The same would mean expressing individual results in a standard fashion such as odd ratio, mean difference or relative risk between the groups.