Medicines have always been the part and parcel of human life, discovered and used in a variety of forms since time immemorial, to cure or get relief from both common and deadly diseases that affect our wellbeing. Earlier, easy home remedies and herbal treatments were predominant in most of the places around the world. The advancement of modern medicine to the current scenario was a gradual process, yet a powerful one, that revolutionized the health industry and influenced the general health pattern of world population to a great extent. The formulation of chemicals to form effective oral or injectable pharmaceutical product has made treatment of illness much easier and efficient for health practitioners. But the knowledge about the origin and processing of such pharmaceutical products and by-products still remain limited or out of reach of common man. People put their entire trust on doctors and pharmacists, who are the only persons aware of the basic information on medicines and its working in a patient's body.
The very first step in the development of a pharmaceutical product is the discovery of the molecule that plays active ingredients in the potential drug. This is achieved either from the information on traditional remedies or by serendipitous discovery. Now, with the development of technologies that allow us to study infections at the molecular and physiological level, it is possible to formulate a drug that targets specific area or entities in the body. The application of bioinformatics tools has made drug designing more convenient and interesting task. Once the curative molecule is discovered, the next steps include the synthesis, characterization, screening and assays for confirming their therapeutic efficiency. After its value is proved through testing, then is the process of drug development which is later followed by clinical trials.
In the product development process, pharmaceutical development is the important part where the discovered therapeutic molecule is turned into medicines that are used for treatment of patients. The aim of the entire process is to develop new or improved high quality drugs in an economic and cost-effective manner so that the final product is supported throughout their life cycle. The product development phase mainly consists of 4 steps- pharmaceutical, non-clinical, clinical and regulatory. In pharmaceutical development, first the discovered molecules are formulated into a medicinal form, mainly as tablets, capsules or injectable forms. Then, a manufacturing method is devised through which the medicine can be continuously reproduced for commercial purpose in large-scale. Afterwards, certain analytical techniques are developed in order to study the properties of the molecule like chemical structure, stability, physical properties and to detect the presence of any impurities. Pharmaceutical maintenance is also done to carry out improvements or changes in formulation, production or analytical phase.
In the attempt to develop the Active Pharmaceutical Ingredient (API) into the final form of medicine, one needs to find the best way to deliver the molecule. This part is handled in the formulation department, where an early stage formulation produces simple forms of the API to be used in toxicological and early clinical testing and late stage formulation deals with the fine tuning of the formulation that eventually becomes the final form of medicine which is marketed. Parallel to this, pharmaceutical analysis progress to examine the properties, content purity, quality and long-term stability of the formulations. Also, process development is carried out, first in bench scale, where the medicine is produced in the lab, then in pilot scale, where the process is systematised to produce the medicinal molecule in exact amounts, and then finally in production scale which becomes the final large scale manufacturing process.
Once the pharmaceutical development is successfully completed, next step is non-clinical development, during which toxicologists and pharmacologists study the interaction of the drug with living systems through in-vitro and in-vivo tests. This provides important information regarding the efficacy of the medicine, side effects if any, and also gives an idea about the dosage and route of administration. The main aim of non-clinical testing is to ensure that the new drug is safe for clinical trials. The final and the most expensive part of product development is clinical trials where the new drug is administered to humans, with due regards to certain regulations set by respective authorities. The clinical trial happens in four phases- first, trials are carried out in normal healthy volunteers to study the biological properties of the medicine and its tolerance level in human. Then a small group of patients are exposed to the drug for preliminary assessment. These two are early stage development. In late stage development, trials are carried out on a large range of patients to study safe and effective doses and later a full scale clinical trial is performed in patients from different parts of the globe to establish its safety and to monitor its long-term safety and efficacy.
When thousands of API are discovered and developed to form medicinal products, only a small part of them reach the production stage. And from them, only a few are considered for clinical trial, and maybe one or two of the new potential drugs reach the market after successful clinical trial. So, development of a pharmaceutical product is not only a complicated and painstaking process, but also very expensive and time consuming. It is true that all medicines that we see in the market now have taken years to go through the whole formulation, development and clinical trials to finally reach us to save our lives!
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