What you have to know about medicinal excipients with more than 100 billion growth space for lips and teeth

TextYYDS

The medicine is composed of raw materials, pharmaceutical excipients and pharmaceutical packaging materials

This topic editor intends to be divided into several modules to introduce medicinal excipients to everyone.

Figure 1 The relationship between the factors that affect the formulation

PART 0 1.

Pharmaceutical excipients refer to excipients and additives used in the production of medicines and formulating prescriptions.

US FDA:

Pharmaceutical excipients are inactive ingredients in preparations other than the main drug (API)

"Japanese Pharmacopoeia":

In addition to the specially specified substances, in order to ensure the properties and quality of the preparations and improve the compliance of the preparations during the storage process, excipients, stabilizers, preservatives, buffers, correctives, and auxiliary agents may be added as needed.

"European Pharmacopoeia"

Medicinal excipients are other constituents in pharmaceutical products except for the active ingredients: adjuvants, stabilizers, preservatives, antioxidants, etc.

International pharmaceutical excipients:

Pharmaceutical preparations that have undergone reasonable safety evaluations do not include active ingredients or precursor components.

The above definitions all highlight the concept that pharmaceutical excipients are inactive ingredients other than APIs, that is, pharmaceutical excipients are inactive ingredients other than APIs, but are excipients really inert? In fact, excipients are not completely inactive substances.

Table 1 Examples of pharmacological supplements homologous

PART0 2.

Figure 2 Classification of pharmaceutical excipients

PART0 3.

Including English common name, chemical name CAS No.

Structure and composition of pharmaceutical excipients:

The structural formula, molecular formula, and molecular weight of excipients, and polymer pharmaceutical excipients should be clear about the molecular weight range and degree of polymerization

Structure identification:

The structure of the product should be clarified in combination with the preparation process route and various structural confirmation methods.

Physical and chemical properties and basic characteristics:

Should include the physical and chemical properties of the excipients, specific information such as: properties (such as appearance, color, physical state), melting point, freezing or boiling point, viscosity, specific rotation, solubility, solution pH, particle size, density (bulk density, Tap density) and functional relevance indicators
.
The mixed excipients should include basic characteristic information such as product properties
.

Impurity control:

Impurity detection and control should be carried out according to the molecular characteristics, source, preparation process, etc.
of pharmaceutical excipients.
For example, for polymer excipients, the focus should be on residual monomers, catalysts, and impurities brought by the production process
.
Evaluate the impact of impurities on the safety and functionality of pharmaceutical excipients, and control accordingly
.

Features:

In combination with the use of excipients in preparations and the route of administration, the standard should include the main functional characteristics of the pharmaceutical excipients and provide detection methods
.
For example, the adhesive needs to specify the surface tension, particle size and particle size distribution, solubility, viscosity, specific surface area, accumulation and other characteristics
.
Other items include residual solvent, related substances, use, category, storage and the like
.

PART 0 4.
Summary

Pharmaceutical excipients play an extremely important role in the key quality indicators of preparations.
Excellent pharmaceutical excipients can not only enhance the stability of active ingredients and prolong the validity period of drugs, but also can better regulate the dissolution or dissolution of active ingredients in and out of the body.
Release behavior
.
Therefore, the choice of excipients is very important, and I hope this article can take you to a new understanding of excipients
.