Challenges In The Development Of High Protein Concentration Formulations Impact of Pharmacotherapy on Drug Delivery Systems

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Impact of Pharmacotherapy on Drug Delivery Systems


Pharmacotherapy can be defined as the treatment and prevention of illness and disease by using drugs of chemical or biological origin. It is among the most important forms of medical treatment, along with surgery, physical therapy, radiation and psychotherapy. Although it is almost impossible to predict the exact extent of the impact of pharmacotherapy on human health, there is no doubt that pharmacotherapy, along with improved sanitation, better food and better housing, has improved people’s health, life expectancy and quality of life.

Unprecedented developments in genomics and molecular biology today provide a wealth of new drug targets. The use of modern methods of chemical synthesis (such as combinator chemistry) enables the synthesis of a large number of new drug candidates in shorter times than before. At the same time, a better understanding of the immune system and rapid advances in molecular biology, cell biology and microbiology allow the development of modern vaccines against old and new challenges.

However, for all these interesting new drugs and vaccine candidates, it is necessary to develop suitable dosage forms or drug delivery systems to allow the effective, safe and reliable use of these bioactive compounds in the patient. It is important to note that the active ingredient is just part of the medicine given to the patient and it is the formulation of the drug in the dosage form or the drug delivery system that translates drug discovery and pharmacological research into clinical practice.

Indeed, the effective drug delivery system plays an important role in controlling the pharmacological effect of the drug as it can influence the pharmacokinetic profile of the drug, the rate of drug release, the location and duration of the drug’s action and then the side effect profile. An optimal drug delivery system ensures that the effective drug is available at the workplace at the correct time and duration.

Drug delivery systems

Drug delivery refers to the methods, formulations, technologies, and processes for transporting a pharmaceutical compound in the body as needed to safely achieve a desired therapeutic effect.

· Physiological drug delivery systems

Based on the physical condition, drug delivery systems may be:

– Gas (eg anesthetics),

Liquids (eg solutions, emulsions, suspensions),

– Semisolid (eg creams, ointments, gels and pastes) and

– Solid dosage forms (eg powders, granules, tablets and capsules).

· Drug delivery systems for administration

Another way to classify dosage forms is by their location or method of administration.

Drug delivery by parents: Drugs can be administered directly into the body, by injection or infusion. Depending on the area of ​​control in the body it can be divided into:

a) Subcutaneous injection

b) Intramuscular injection

c) Intravenous injection

d) Intradermal injection

e) Intraperitoneal injection

Oral drug delivery: The oral route is the most popular route of drug administration. Suspensions, pills, capsules, etc. are administered in this way.

– Topical drug delivery: Drugs can be injected through the skin to enter the body. Mostly semisolid dosage forms are used for this, including creams, ointments, gels and pastes. However, liquid dosage forms, such as emulsions, or solid dosage forms, such as transdermal controlled drug delivery systems (pieces), can also be used.

– Transmucosal: These drugs are administered by nasal, buccal/sublingual, vaginal, ocular and rectal routes.

· Drug delivery systems by drug release method

Another system that can be used to classify drug delivery systems is according to how the drug is released. It can be divided into:

– Immediate release – the drug is released quickly after administration.

– Modified release – drug release occurs only after administration or for a long time or at a specific target in the body. Modified release systems can be further classified as follows:

a) Delayed release: the drug is released only at a certain time after the first administration.

b) Extended release: prolongs the release time to reduce the frequency of dosing

– Sustained release: These systems maintain the rate of drug release over a sustained period of time.

– Controlled release: Controlled release systems also provide a sustained release profile but, unlike sustained release forms, controlled release systems are designed to lead to predictable plasma concentrations, independent of the biological environment of the application site. This means that they actually control the concentration of the drug in the body, not just the release of the drug from the dosage form, as is the case with a sustained release system.

– Targeted drug delivery (strategic drug delivery): It is a method of delivering the drug to the patient in a way that increases the concentration of the drug in some parts of the body compared to others. The aim of the targeted drug delivery system is to increase the duration, residence, targeting and interaction of the protected drug with the diseased tissue.

Disease and Drug Delivery System Design

A disease is an abnormal condition that affects the body of an organism. It is often considered a medical condition associated with specific signs and symptoms. It can be caused by factors from an external source, such as an infectious disease, or it can be caused by internal dysfunction, such as autoimmune diseases, sometimes including injuries, disabilities, disorders, syndromes, diseases, independent symptoms, deviant behavior, and general structural and functional changes.

Medical treatment is an attempt to cure or improve a disease or other health problem. A number of drug molecules have been developed but the development of a new drug molecule is expensive and time-consuming. Therefore, improving the effectiveness of “old” drugs is considered a good idea. This has been attempted by developing new drug delivery systems that aid in individualized drug therapy, dose titration, and drug monitoring with ease. Drug delivery at a controlled rate, slow delivery, targeted delivery are very attractive and strongly pursued approaches. Drug delivery systems change the profile of drug release, absorption, distribution and elimination with the benefit of improving the efficiency and safety of the product. It also ensures patient convenience and compliance.

There are drug molecules that show specific drug release eg peptides and proteins. Such drugs cannot show their action without a proper drug delivery system. Thus, an increasing number of peptide and protein drugs under investigation require the development of dosage forms that exhibit site-specific release. Systemic drug delivery through colonic absorption represents a new way to introduce peptide and protein drug molecules and poorly absorbed drugs into the gastrointestinal (GI) tract. Single-colonic drug delivery systems offer clear advantages over parenteral administration. Targeting the colon naturally has value in the topical treatment of colon diseases such as Crohn’s disease, ulcerative colitis and colon cancer. Continuous colonic excretion of drugs may be useful in the treatment of nocturnal asthma, angina and arthritis. Peptides, proteins, oligonucleotides and vaccines are interesting candidates for colonic drug delivery. Sulfasalazine, ipsalazide and olsalazine have been developed as colon-specific delivery systems for the treatment of inflammatory bowel disease (IBD).

Worldwide, more than 40 million people are infected with the Human Immunodeficiency Virus (HIV). High Activity Antiretroviral Therapy (HAART) combines at least three antiretroviral (ARV) drugs and, for more than a decade, has been used to prolong the lives of HIV-infected patients. Chronic HAART intake is mandatory to control HIV infection. The frequent administration of many drugs in very high doses is the main cause of patient non-compliance and an obstacle to the completion of pharmacotherapy. High adherence to HAART does not lead to complete eradication of HIV in the recipient. Intracellular and anatomical viral reservoirs are responsible for further infection. Active transport mechanisms involving proteins of the ATP-binding cassette superfamily inhibit the entry of ARV drugs into the brain and may explain their limited bioavailability after oral administration. New research dealing with simple organoleptic or technical problems in more complex matters involving the targeting of specific tissues and organs has emerged. With the goal of reducing dosing frequency, improving compliance with existing pharmacotherapy and targeting viral sources, the design of drug delivery systems is becoming increasingly relevant to new drug discovery.

To conclude

Whenever someone is sick with a disease, they need medical treatment and each of us chooses the one that is safe, effective, economical and appropriate. This can only be achieved through the development of an effective drug delivery system. Regardless of how the dosage forms are classified, the role of drug delivery systems is to allow effective, safe, and reliable administration of the drug to the patient.

For effective pharmacotherapy, delivery systems must allow and facilitate the drug to reach its target site in the body. For example, the formulation of a tablet containing an antihypertensive drug must be dissolved in the gastrointestinal tract, the drug needs to dissolve and the dissolved drug needs to pass through the mucosal membrane of the gastrointestinal tract in the body. Therefore, in the development of dosage forms synthetic science should increase the availability of the drug.

Similarly, the delivery system allows for the safe use of the drug. This includes that the drug in the formulation must be chemically, physically and microbiologically stable. Side effects of drug-drug interactions should be avoided or minimized through the use of appropriate drug delivery systems. Delivery systems should also improve patient compliance with pharmacotherapy through the development of appropriate applications. For example, one can improve patient compliance by developing an oral dosage form where previously only parental request was possible.

Finally, the delivery system must be reliable and its design must be technically feasible. However, for any application of a drug delivery system to the market, the dosage form must be produced in large quantities and at a low cost to make affordable drugs available. Therefore, it is necessary to investigate the feasibility of the developed systems to be scaled up from the laboratory to the production scale.

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