Formulation development is one of the first points where the pharmaceutical supply chain begins. It is basically the place where different chemical substances are blended together focusing on the final goal of creating the medication that will eventually be used for a specific illness or condition.
The formulation development process begins by a consultation with a chemist experienced at working with the particular types of chemicals needed to be tested by the client. After the consultation, the chemist will discuss the client’s needs with his or her team of scientists, and they will draw up and submit a proposal for the job. The proposal having been accepted, the team of chemists will get to work on what is called a prototype, the finished product to be reviewed by the client. A prototype is a precursor to the product, a mock up, so to speak, that gives the team a foundation to work from. After the prototype is reviewed, the scientific team will again go to work to make the changes needed and suggested by the client in order for the formulation to be developed into the finished product.
In performing the formulation development, the team of chemists is performing certain steps. They are finding and testing certain raw materials, they are matching the product with the appropriate packaging, they are testing the shelf life of the product, and they are doing everything necessary to be sure that the finished product meets with all required regulations. Finally, they settle on the right manufacturer to produce the medication.
There are several types of medical packaging materials that are used in the encasing of medications. The most common is medical blister packaging, which is a transparent card that is shaped right over the product, which is usually in pill form, sealed together with blister board backing through a heating process. Several types of blister packaging are Tyvek backing, blister cards, E flute blister cards, and foil backing. Many medications are dispensed in blister packaging, which is formed to be peeled open, one dose at a time.
Other common types of medical packaging design are bottle packaging designs, prefilled syringes, and clinical packaging. Some of these types of medical packaging are done in several different ways, depending upon whether or not they need to be packaged by the dose or another form specified by medical professionals. Medications packaged in bottles typically have a twist off cap, or a cap that snaps off; however, all bottled medications are child resistant. Pouch packaging is most often used for liquid medications, but can also be used for medicated powders and ointments.
Formulation development is an ongoing process that is virtually an open-ended operation. There will always be need for this process, especially in the medical field, because of the continuing need for the thousands of different kinds of medications by the public. Statistics show that 75.1% of all doctor or emergency room visits will end with the patient leaving with a prescription for at least one type of medication. Formulation development is always conducted and performed by qualified person services, which would be, as mentioned earlier, a team of trained chemists, or scientists. In addition, before formulation development is begun, there is a process that needs to be done called preformulation.
Preformulation is exactly what it says it is. It is a harbinger, or a messenger, to the formulation process whereby a study is done of the properties of the drug to determine what other constituents would be best added to it to reach the finished product. A study is then performed to check the stress properties of the chemical in order to gain an idea of its safety and durability under extreme conditions. This entire process is carried out before formulation development can begin. It is essential to know what other properties the chemical will be compatible with, and in what measure, when formulating a medication designed to relieve pain or even to save lives.
After medications are manufactured and packaged, they go through a pharmaceutical serialization process. This is a process that assigns each package a unique set of numbers that will distinguish it from other medications. This is designed for easy tracking and to discourage illegal duplication of the drug.
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