The concept of preformulation It is used in the field of pharmacy to refer to the development of research aimed at determine the compatibility of the substances that make up a pharmaceutical form. This work is key to obtaining a final product that is in a position to meet your specific objectives.
It should be remembered that pharmaceutical form or galenic form it is established from a precise combination of substances to make administering a medicine easier. This shape makes the active principles and the excipients of the drug are adapted to a certain arrangement.
The preformulation seeks to provide useful information for the proper development of the formulation. That is why it contemplates multiple studies on the composition and presentation of drugs.
Among the issues that are analyzed in the preformulation stage are the physical and chemical properties of drugs. The solubility, stability and reactivity, for example, are closely watched.
Another aspect that is considered in the preformulation is the capacity of the substances to reach the point of action and thus achieve the triggering of the intended biological response.
It is common for preformulation to be associated with QA. This work, which includes the choice of active ingredients, excipients, the manufacturing process and the most suitable packaging, enables the final product to meet the needs raised. The preformulation also contemplates the definition of the toxicological strategy, establishing which are the limits of the components.
Pharmaceutical development is essential today, since for decades we have depended on drugs to maintain and improve our state of Health. In particular, this field seeks the development of products (medicines) that meet a well-defined set of requirements: elegance from a pharmaceutical perspective; the uniformity of its content; stability throughout its life (previously estimated); that have adequate bioavailability; that can be produced in the relevant industry.
Reviewing the objectives of the preformulation, we can say that the information it intends to provide should be useful for the following points:
* the developing appropriate formulation, and this includes the form in which the drug in question is presented (polymorph, salt, etc.), its composition, its physical structure and its excipients;
* the process in which the final form of the drug and the final product must be obtained. This point includes other phases, such as filtration and the technological process;
* find a drug whose biopharmaceutical behaviors respond to a well-defined set of expectations;
* elaboration of the so-called analytical methods to quantify medications monitor your purity, including its impurities and its degradation products. These methods must be simple, sensitive, specific and possible to reproduce in order to be considered valid in the process.
With all this information, it is possible to proceed to the creation of a preformulation program, which addresses certain activities that test the feasibility of the dosage and give rise to a series of studies mentioned above to define the properties:
* chemical: The first branch is presented here, which can lead to a solid, a liquid or a gas. In the case of a solid, its shape, its base and its type of salt, among other aspects, must be studied. Organoleptic properties, reactivity, purity and stability (its pH, humidity, etc.) also come into play;
* physical: the description of its structure in a diagram, the characteristics of fluidity, static electricity and its particles, its crystalline structure and certain variables such as its partition coefficient, the speed of its dissolution and its solubility;
* biological: the ability of the drug to gain access to the point of action and lead to the expected biological response.