In
pharmaceutics
Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design. The ...
, micromixing is a process in which ingredient particles rearrange to form a
blend
A blend is a mixture of two or more different things or substances; e.g., a product of a mixer or blender.
Blend
Blend may also refer to:
* Blend word, a word formed from parts of other words
* ''Blend'' (album), a 1996 album by BoDeans
* Bl ...
. Development of
pharmaceutical formulation
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word ''formulation'' is often used in a way that includes dosage ...
s requires understanding how the ingredients blend with each other and how the blending progresses through different stages. It is also important to establish in a scientific manner when the blending is considered complete, establishing the margins of blending performance, so that in production the blending is complete before the blending process stops.
Optimal blending
In order to achieve optimal
blending, the micromixing process must be studied to determine mixing parameters such as blending time, blending speed, type and size of blender. When blending is performed too long, overblending may occur, with particles re-aggregating, resulting in segregation of the previously ideal blend.
Tools
Formulation
scientist
A scientist is a person who conducts Scientific method, scientific research to advance knowledge in an Branches of science, area of the natural sciences.
In classical antiquity, there was no real ancient analog of a modern scientist. Instead, ...
s and
technologist
Technologist may refer to:
* Applied Science Technologist, a Canadian professional title in engineering and applied science technology.
* Architectural technologist, a specialist in the technology fields of building, design and construction.
* C ...
s need tools to select ingredients for new formulations.
Tablet
Tablet may refer to:
Medicine
* Tablet (pharmacy), a mixture of pharmacological substances pressed into a small cake or bar, colloquially called a "pill"
Computing
* Tablet computer, a mobile computer that is primarily operated by touching the s ...
s contain multiple ingredients beyond the active pharmaceutical ingredients (API) such as fillers, tableting agents,
disintegrants, and
absorption
Absorption may refer to:
Chemistry and biology
* Absorption (biology), digestion
**Absorption (small intestine)
*Absorption (chemistry), diffusion of particles of gas or liquid into liquid or solid materials
*Absorption (skin), a route by which ...
enhancers or agents that slow down and control absorption. Choice of materials is important to assure the flow characteristics, potency, and absorption of specific formulations. In addition, proper particle size grades of the ingredients must be selected to produce an optimum blend for capsule filling.
Methods
In order to study the rate and uniformity of blending, destructive analytical methods, such as
dissolution
Dissolution may refer to:
Arts and entertainment Books
* ''Dissolution'' (''Forgotten Realms'' novel), a 2002 fantasy novel by Richard Lee Byers
* ''Dissolution'' (Sansom novel), a 2003 historical novel by C. J. Sansom Music
* Dissolution, in mu ...
followed by
chromatographic
In chemical analysis, chromatography is a laboratory technique for the separation of a mixture into its components. The mixture is dissolved in a fluid solvent (gas or liquid) called the ''mobile phase'', which carries it through a system (a ...
separation and detection are often used. These methods require samples to be pulled from the blend, followed by time-consuming laboratory analysis. In production, such analysis delays may lengthen time required for production formulation development.
Hyperspectral imaging
Near-
infrared
Infrared (IR), sometimes called infrared light, is electromagnetic radiation (EMR) with wavelengths longer than those of visible light. It is therefore invisible to the human eye. IR is generally understood to encompass wavelengths from around ...
hyperspectral imaging
Hyperspectral imaging collects and processes information from across the electromagnetic spectrum. The goal of hyperspectral imaging is to obtain the spectrum for each pixel in the image of a scene, with the purpose of finding objects, identifyi ...
can show the distribution of ingredients in pharmaceutical tablets. In addition to
laboratory analysis, imaging of near line pull-samples has been used to indicate whether the mixing endpoint has been achieved. However, such
measurement
Measurement is the quantification of attributes of an object or event, which can be used to compare with other objects or events.
In other words, measurement is a process of determining how large or small a physical quantity is as compared ...
s were performed once blending was completed, and therefore, did not yield information about the progression of micromixing during the blending process.
[Micromixing Analysis for Formulation Developers, Gabor J Kemeny, Gina Stuessy, Natalie Crothers; American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition, October 2011, Washington, DC]
poster
)
References
Further reading
* Marbach, Ralf. (2007)
{{Refend
Pharmaceutics
Pharmacy