While there are large steps involved in the development of any new pharmaceutical product, there are also sub-steps within each phase of the process. It is essential for any pharmaceutical contract manufacturer to be familiar with these steps within the phase to ensure full compliance with all testing, analysis and verification and validation requirements essential for drug approval.
The formulation and development of tablets, which is also known as the dosage development stage, is critical in the process of bringing a new drug to market. It builds on the analysis and testing from the preformulation phase to be able to turn information about the chemicals in the drug into a formula and dosage form that is effective for the patient and also ensure the safety and stability of the medication.
In the formulation and development of tablets, both API (Active Pharmaceutical Ingredients) as well as nondrug, inactive ingredients will be combined. These combinations of active and inactive ingredients cannot result in a change of the chemical of physical properties of each other. They also have to be bioavailable, which means they are absorbed by the body at a specific rate and without change from the dosage form.
In the formulation and development of tablets, the research will also focus on the best form of tablet to consider. For example, based on the properties of the pharmaceutical product it may be advantageous choose a micro layer tablet formulation.
For some tablets, particularly for time release types of medications, it may be beneficial to consider a multi-layer tablet for the dosage form. These multiple layers can allow for the different timed release of the medication or even combinations of medications in the layers that allows a single dose to provide different APIs at different points in time.
There are many different factors that go into these state-of-the-art medication dosage forms. Choosing the right option takes time, research and understanding of the intended use of the medication.
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