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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5320_Библиотеки_им_академика_М_И_Перельмана
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326
19.2 Production of Powders and Granules
Pharmaceutical Dosage Forms and Drug Delivery
usage.
19.2.1 Origin of Powdered Excipients
• Natural origin: animal products
•
• Natural origin: plant products
•
•
from these processes is dried and milled before use in pharmaceutical formulations. Starch is used
•
• Semisynthetic product
•
•
granulation.
• Synthetic product
•
•
in situ
•
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Powders and Granules
19.2.2 Origin of Powdered Active Pharmaceutical Ingredients
327
19.2.3 Amorphous and Crystalline Powders
amorphous in nature.
•
long- range indicates
•
19.2.4 Production of Crystalline Powders
the solvent.
• Evaporation of solvent from a solution.
• -
temperature).
•
•
•
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328
19.2.4.1 Crystallization Versus Dissolution
Pharmaceutical Dosage Forms and Drug Delivery
19.2.4.2 Polymorphism
•
•
•
form over another is often attributable to the higher strength of intermolecular interactions and/ or closer
preferred for use in a drug product.
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Powders and Granules
19.2.5 Production of Amorphous Powders
329
evaporation from a solution of the solute can result in the precipitation of solute in an amorphous form.
®
release properties.
19.3 Analyses of Powders
•
•
19.3.1 Particle Shape and Size
19.3.1.1 Defining Particle Shape and Size
Figure 19.1, particles
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330
FIGURE 19.1
Pharmaceutical Dosage Forms and Drug Delivery
1 -
2
a shape from a perfect sphere.
equivalency
19.3.1.2 Defining Particle Size Distribution
•
lognormal.
• -
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Powders and Granules
331
19.3.1.3 Desired Particle Shape and Size
•
•
•
-
cessing equipment during pharmaceutical manufacturing.
19.3.1.4 Factors Determining Particle Shape
19.3.1.5 Techniques for Quantifying Particle Shape and Size
• Sieve analysis
dd d
3
++
ddd
3
++
ddd
3
++
ddd
ddd
13233
++
++
ddd
ddd
12223
++
++
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TABLE 19.1
Statistical
Parameter
d(90), d
d(10)
d[1,0]
Nomenclature or Meaning
of the Parameter Calculation of the Parameter Equation Comments on Its Usage
Percentile calculation
this diameter (of an equivalent
sphere)
number mean diameter
number of particles in the denominator
For three particles of
diameter d1, d2, and d3,
123
10
,
=
[]
manufacturing
Represents the mean diameter of a sphere of
equivalent diameter to the particles of the
332
d[2,0]
d[3,0]
d[4,3]
d[3,2]
Sauter mean diameter, surface area
volume mean diameter, number
moment mean diameter
sum of squares of diameter terms in the
the number of particles in the denominator,
the sum of cubes of diameters of particles in
the sample
of squares of diameters of particles in the
sample
For three particles of
diameter d1, d2, and d3,
20
[]
12223
,
=
For three particles of
diameter d1, d2, and d3,
3
30
,
=
[]
13233
3
For three particles of
diameter d1, d2, and d3,
14243
43
,
=
[]
4
3
For three particles of diam-
eter d1, d2, and d3,
13233
32
,
=
[]
3
2
Represents the mean diameter of a sphere of
equivalent surface area to the particles of
2
Pharmaceutical Dosage Forms and Drug Delivery
Represents the mean diameter of a sphere
Represents the mean diameter of a sphere of
d[3,0]
because the calculation of d[4,3] does not
require the number of particles
Represents the mean diameter of a sphere
of equivalent surface area to the particles
d[2,0]
because the calculation of d[3,2] does not
require the number of particles
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Powders and Granules
• Laser diffraction analysis
• Focused beam reectance measurement (FBRM): In situ
-
ical processing, such as granulation. A fast- spinning laser beam is focused on the sample through
the speed of laser light are used to calculate the length of a particle passing through the focus of
particles produces a chord length distribution. Changes in the chord length distribution during pro-
• Microscopy
introduce bias into the sample. It is a qualitative tool for most of the applications. Automated image
of several hundreds or thousands of particles in a sample.
• Sedimentation
dispersed phase and the dispersion medium leads to particle separation. Sedimentation is not a pre-
assessment of superdisintegrants, such as croscarmellose sodium, and separation of particles of
• Electrozone sensing
for counting biological cells and bacteria, using a coulter counter.
333
and principle of operation is provided in .
19.3.1.6 Changing Particle Shape and Size
Milling odd- shaped particles, such as needles, tend to reduce their aspect ratio and change their shape
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TABLE 19.2
Approximate
Technique Principle
particle diameter
Angle of scatter of incident laser
Focused beam
measurement
of incident laser light,
depends on the chord length
surface
Particle Size Range Disadvantages and Limitations Advantages and Applications
pharmaceutical granules
-
agglomerated materials
particle orientation and sieving time determine
requiring operator training, careful selection of
dispersion medium, and method development for
operator training and method development for
pharmaceutical manufacturing processes
334
Pharmaceutical Dosage Forms and Drug Delivery
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Sedimentation
assisted separation of the
dispersed phase from the
dispersion medium
Changes in electrical conduct-
an aperture as nonconducting
dispersed phase passes
through
preparation on unrepresentative observation
monitoring tool
interparticle interactions
• Requires suspension of particles in a conducting
Powders and Granules
the observation of birefringence
• Rapid and reliable method for total particle
counting
blood samples
• Pharmaceutical applications limited to research
investigations
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