Tuesday 22 September 2015

Basic pharmacy terms/definations part 3

Empty Capsule Shell Weight & Capsule fill volume / weight capacity according to the density of the powder.


Dimensional Specification:
The following specifications apply to Capsugel hard gelatin capsules.

Weight:
The average capsule weight of an order is estimated by a representative sample average of 100 capsules falling within the limits given bellow:
(values in mg for one capsules)
Size
Target (mg)
Limits (mg)
000
163
150 – 176
00
122
112 – 132
0 el
112
103 – 121
0
96
86 – 105
1
77
69 – 85
2
62
56 – 68
3
49
44 – 54
4
39
36 – 44
5
27
24 - 36
A moisture content of 14% to 14.5% is assumed upper and lower limits are given at the 99.9% confidence level.
In empty hard gelatin capsule production wall thickness is carefully monitored and controlled by the regulation of gelatin solution viscosity. However, since the physical properties of raw gelatin are not constant. Solution density may vary and affect the resultant capsule weight. Therefore the above target weight should not be used as tare weights in capsule filling samples from the actual batch being filled should be taken as tare weights.

Capsule capacity:
The average capsule volume and filled capsule weight capacity for typical powder dose densities is as follows:
Capsule Size
Capsule Volume ML of Water
Capsule weight capacity in mg
Powder dose density
0.6 g/cc
0.8 g/cc
1.0 g/cc
1.2 g/cc
000
1.37
822
1096
1370
1644
00
0.95
520
760
950
1140
0 el
0.78
458
624
780
936
0
0.68
408
544
680
816
1
0.50
300
400
500
600
2
0.37
222
296
370
444
3
0.30
180
240
300
360
4
0.21
126
168
210
252
5
0.13
78
104
130
156
















The above data are to be considered as approximations since filling product variables and filling machine type can significantly affect the capsule weight capacity.




What is training ? What are the functions of Qualified and key personnel in a Pharmaceutical Industry ? 

Basic pharmacy terms/definations part 2

Rheology, Viscosity, Shearing Stress, Dispersed System, Colloidal Dispersion, Colloids & Coarse Dispersion.



Rheology:
Rheology is the study of the flow and deformation properties of the matter.
Viscosity:
The viscosity of a fluid is its resistance to flow or movement.
According to flow, fluids are of two types. They are:-
1.       Newtonian Fluids &
2.       Non- Newtonian Fluids.
1.       Newtonian Fluids:- Liquids which follow Newton’s law of viscous flow are known as newtonian’s liquids.
2.       Non-Newtonian Fluids:- Liquids which do not follow Newton’s law are known as non-newtonian fluids.
Example: Colloidal dispersion, emulsions, suspensions and ointments.
Shearing Stress:
The force per unit area F/A required to bring about flow is called the “Shearing Stress”
·         The flow properties of Non-Newtonian Materials are three types. They are:-
1.       Plastic flow
2.       Pseudo plastic flow
3.       Dilatants flow.
Dispersed System:
A dispersed system is defined as a system in which one phase, the dispersed phase, is distributed uniformly as particles throughout another phase, called the sispersion medium or continuous phase.
Colloidal Dispersion:
If the particles have a size ranging from 1 nm to 1 µm, which is dispersed in the continuous phase, this system is called colloidal dispersion.
Colloids:
The particles have a size ranging from 1 nm to 1 µm is called colloids.
Because of their large surface area, colloids show greater efficiency for absorption or adsorption.
 
Coarse Dispersion:
The size of the dispersed particles ranging from 1 µm to 100 µm, which is dispersed in the continuous phase, this system is called coarse dispersion.

Basic pharmacy terms/definations 1

Tonicity, Isotonic solutions, Hypotonic solutions, Hypertonic solutions, Interface, Surface, Absorption, Adsorption, Surface tension, Solubilization, Polymorphism






Tonicity:
Tonicity is measure of the osmotic pressure of two solutions separated by a semi permeable membrane.

Isotonic solutions:
Two solutions are said to be iso-osmotic or isotonic if they exert the same osmotic pressure when separated by a semi permeable membrane.
Example: 0.9 % solutions of NaCl is said to be isotonic solutions.

Hypotonic solutions:
Solutions with osmotic pressure lower than that of the body fluids or of 0.9% NaCl solution are called hypotonic solution.

Hypertonic solutions:
Those solutions having a higher osmotic pressure than the body fluids or of 0.9% NaCl solutions are called hypertonic solution.

Interface:
The boundary between two phases is generally described as an interface.

Surface:
When one of the phases is a gas or a vapor and the other a liquid or solid, the outer space of the phases which is contacted or exposed with the outer space of other phases is called surface of that phase.

Absorption:
Absorption is the incorporation of a substance in one state into another of a different state.

Adsorption:
Adsorption is the adhesion of atoms, ions, biomolecules or molecules of gas, liquid, or dissolved solid particles to a surface.

Surface tension:
Surface tension is a property of the surface of a liquid that allows it to resist an external force.

Solubilization:
The process by which water insoluble or partly soluble substances are brought into aqueous solution by incorporation into micelles is termed as solubilization.

Polymorphism:
Polymorphism is the ability of a compound(or element) to crystallize as more than one distinct crystalline species with different internal lattices.
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