What is a medicine or drug?
A medicine is a chemical substance which can be defined as an agent intended for use in:
Diagnosis – Identification of the nature of illness or disease in man or animal,
Mitigation – Action of reduction of the severity of disease in man or animal,
Treatment – Manner in which we use the drug or treatment for treating any disease in man or animal,
Cure – Provided relief from a disease in man or animal, or
Prevention – Protects a man or animal from a disease.
What is pharmaceutics?
The science of dosage form design is called pharmaceutics. It is the discipline of pharmacy that directly deals with the process of turning new chemical entities or old dosage forms into a medication that can be safely and effectively used by patients.
The field of Pharmaceutics specifically deals with formulation development, packaging, stability & marketing of the new dosage form. In the development process of a new dosage form, pharmaceutics gives special attention on issues such as how many drugs to be used in creating the new dosage form, the quantities of drug to be used and how much drug will be effective for treating the disease.
Developing a new drug or a new dosage form from an old drug form are also examples of New Chemical Entities. Such New Chemical Entities can be newly synthesized or obtained naturally. Examples of dosage forms include tablets, capsules, powder, granules, pills, syrups etc.
Dosage Forms
Dosage forms are the means by which a drug molecule or an API (Active Pharmaceutical Ingredients) is delivered to the site of action within the body to produce optimum desired effects and minimum adverse effect.
For example, almost everybody knows about a Paracetamol tablet which is commonly used to treat headaches and fever. In a Paracetamol tablet, Paracetamol is the API or the Active Pharmaceutical Ingredient and tablet is the dosage form. To have the right effect and provide the precise pharmacological action, the API which is Paracetamol has to reach the site of action, which is the brain, and then have the exact pharmacological action, and treat the headache. Without a dosage form such as tablet, this whole process would have faced several barriers and its impact on the site of action would have suffered as a result.
What is Dosage form made from?
Dosage form is made from API and Excipients. While APIs (Active Pharmaceutical Ingredient) show the pharmacological action, excipients help in increasing the bulk of the API and provides stability to the API so that the API can cross the barriers and reach the site of action.
All APIs have a pharmacological action which needs to be identified. Depending on the disease the dose of API varies, however the API in itself is not sufficient to reach the site of action and requires additional excipients to create a practical dosage form.
Please note that excipients do not increase or decrease the therapeutic action of any active ingredient. It is interesting to note here that excipients are generally inert in nature and don’t have any pharmacological action.
Examples of excipients include binding agents, sweetening agents, flavoring agents or preserving agents. Acfording to the dosage form the exceipients are selected and converted into a dosage form.
Why are dosage forms required?
Dosage forms are primarily required for 3 main purposes:
Providing a safe and convenient delivery of accurate dosage. For example, tablets, capsules or syrups.
Concealing the bitter taste or odor of the API. For example, Coated tablets or flavored syrups.
Protection of drug substances from atmospheric oxygen or moisture. For example, coated tablets or sealed ampoules.
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