The Student Room Group

What is drug formulation

Is it the process of forming drugs or is it the final product?


Also what is the definition in this context:
"Is drug formulation a science?"
Original post by app_
Is it the process of forming drugs or is it the final product?


Also what is the definition in this context:
"Is drug formulation a science?"

Drug formulation refers to the process of developing and forming a drug. The term drug formulation includes preclinical and clinical stages whereby the drug undergoes thorough testing on cells, tissues, animals, healthy human volunteers and finally the targeted group. The term is purposefully broad as drug formulation is like a learning curve - you never truly know how different species might react to the drug and you need to constantly monitor and sometimes even chemically modify the drug.

As to whether the process is science or luck that is a heavily subjective question. One could argue that the use of thalidomide for morning sickness and the use of isotretinoin to treat severe acne (although both medications were developed for, and initially used to treat different disease/conditions) best exemplifies the aspect of "luck" or "chance" in the process of drug formulation because the diversity of the use of the drug and its potential remains a partial mystery. But then you can also point to the scientifically rigorous process of developing the drug, the analysis of data and the time spent developing one as the scientific aspect of the process. But in the end, as I said, the question remains largely subjective and is open to different interpretations.

P.S. Is this for the Cambridge Sixth Form essay competition?
Hi, actually what New Wonder has described is not drug formulation but drug research and development, which involves the processes, in that order, of the identification of a chemical moiety, the determination of its pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drug = absorption, distribution, metabolism and excretion) first in animal models and later through Phases 1-4 of clinical trials in human volunteers and patients, followed by regulatory affairs approval which then permits the issue of a product license for the drug to be prescribed by a doctor and/or dispensed by a pharmacist.

DRUG FORMULATION refers to the manufacture of the drug in terms of its dose, chemical state, its solubility and chemistry that determine its absorption and dissolution in the stomach/intestines, the chemistry of the outer layer of e.g. a capsule [which is often sugary to make the drug "palatable"], other features such as methods that make it a sustained release drug to prolong or even out its effects, the added chemicals called adjuvants, etc.

The study of the formulation of drugs [taught to pharmacy students] is called pharmaceutics.

As for your 2nd Q, YES definitely it is a science - the factors that determine how to make a tablet, capsule, liquid for injection, a suppository, a pessary, a cream, an ointment, etc in order to achieve optimal therapeutic objectives are logical scientific principles based on the science of biochemistry and medicinal chemistry. Having said that, any biomedical science is not a precise science, simply because of individual variation between patients that is the result of genetic variability and environmental differences. The nature (qualitative) and extent (quantitative) of effects of any drug can vary depending on several factors, e.g. age [liver and kidney function might be reduced in young children and in the elderly, thus increasing the effect of the drug as less is excreted per unit time], sex, other pathology [e.g. an inflamed conjunctiva will increase the absorption of drugs into the eye; a compromised state of cardiovascular function will result in reduced blood flow to the gut with resultant reduced absorption of a drug; etc], the acid-base status, etc etc etc.

I am sure there are books and research papers on pharmaceutics online - have a quick glance.

Hope this clarifies things!
M (clinical pharmacologist)
Reply 3
Original post by New Wonder
Drug formulation refers to the process of developing and forming a drug. The term drug formulation includes preclinical and clinical stages whereby the drug undergoes thorough testing on cells, tissues, animals, healthy human volunteers and finally the targeted group. The term is purposefully broad as drug formulation is like a learning curve - you never truly know how different species might react to the drug and you need to constantly monitor and sometimes even chemically modify the drug.

As to whether the process is science or luck that is a heavily subjective question. One could argue that the use of thalidomide for morning sickness and the use of isotretinoin to treat severe acne (although both medications were developed for, and initially used to treat different disease/conditions) best exemplifies the aspect of "luck" or "chance" in the process of drug formulation because the diversity of the use of the drug and its potential remains a partial mystery. But then you can also point to the scientifically rigorous process of developing the drug, the analysis of data and the time spent developing one as the scientific aspect of the process. But in the end, as I said, the question remains largely subjective and is open to different interpretations.

P.S. Is this for the Cambridge Sixth Form essay competition?

Thank you very much!

It is indeed for the Cambridge Essay Competition.
Are you doing it as well?
Reply 4
Original post by macpatgh-Sheldon
Hi, actually what New Wonder has described is not drug formulation but drug research and development, which involves the processes, in that order, of the identification of a chemical moiety, the determination of its pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drug = absorption, distribution, metabolism and excretion) first in animal models and later through Phases 1-4 of clinical trials in human volunteers and patients, followed by regulatory affairs approval which then permits the issue of a product license for the drug to be prescribed by a doctor and/or dispensed by a pharmacist.

DRUG FORMULATION refers to the manufacture of the drug in terms of its dose, chemical state, its solubility and chemistry that determine its absorption and dissolution in the stomach/intestines, the chemistry of the outer layer of e.g. a capsule [which is often sugary to make the drug "palatable"], other features such as methods that make it a sustained release drug to prolong or even out its effects, the added chemicals called adjuvants, etc.

The study of the formulation of drugs [taught to pharmacy students] is called pharmaceutics.

As for your 2nd Q, YES definitely it is a science - the factors that determine how to make a tablet, capsule, liquid for injection, a suppository, a pessary, a cream, an ointment, etc in order to achieve optimal therapeutic objectives are logical scientific principles based on the science of biochemistry and medicinal chemistry. Having said that, any biomedical science is not a precise science, simply because of individual variation between patients that is the result of genetic variability and environmental differences. The nature (qualitative) and extent (quantitative) of effects of any drug can vary depending on several factors, e.g. age [liver and kidney function might be reduced in young children and in the elderly, thus increasing the effect of the drug as less is excreted per unit time], sex, other pathology [e.g. an inflamed conjunctiva will increase the absorption of drugs into the eye; a compromised state of cardiovascular function will result in reduced blood flow to the gut with resultant reduced absorption of a drug; etc], the acid-base status, etc etc etc.

I am sure there are books and research papers on pharmaceutics online - have a quick glance.

Hope this clarifies things!
M (clinical pharmacologist)

Hi M,

Thank you very much for your reply!

Could you please link me with some of those papers? I can't seem to find suitable ones
Yes but I am doing a different question.
Reply 6
Illegal
Reply 7
Original post by New Wonder
Yes but I am doing a different question.

which question?
Original post by app_
which question?


What defines a species, and whether we can call ourselves one when evidence shows our genes are a mixture from our ancestors which, although able to interbreed, were different species.

How is your essay going?
Reply 9
Original post by New Wonder
What defines a species, and whether we can call ourselves one when evidence shows our genes are a mixture from our ancestors which, although able to interbreed, were different species.

How is your essay going?

bit of a dead end lool. How about yours?

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