NON-STERILE Liquid Dosage Forms Flashcards
Qualitative description of the dosage form
Description
NON-STERILE Liquid Dosage Forms
a. Solutions
b. Suspensions
c. Emulsions
(should remain clear under temp (4-47 C)
odor, color, taste, clarity
Solutions
Description
Stability
Physico-chemical tests
pH, Viscosity, Optical activity, Refractive index
Physico-chemical tests
manifested physically
Stability
the ratio of the ultimate volume of sediment (Vu) to the original volume of sediment (Vo) before settling
Sedimentation Volume
ideal size is 2μm
Size of particles
the amount of the force necessary
Redispersibility
determines the repulsive forces between particles à stability
Zeta Potential
The ways materials deform and flow when force is applied.
Rheological properties
Suspensions
Sedimentation Volume
Size of particles
Redispersibility
Zeta Potential
Rheological properties
Emulsions
Electrophoretic analysis (Zeta Potential) Particle size number analysis
Gravitational and temperature stress tests
Test for creaming, cracking, phase separation, phase inversion
pH
determine whether a product complies with compendial specifications for microbial quality and quantity.
Microbial Limit test
Screen for the presence of:
E. coli
Salmonella species
S. aureus
P. aeruginosa
Bile-Tolerant Gram Negative Bacteria
C. albicans
Clostridium species
Determines whether the product will deliver the dosage form as stated in the label
Deliverable volume
PDG
Pharmacopoeial Discussion Group
a statement in their respective texts which indicates that the procedures and acceptance criteria from all three pharmacopeias are considered equivalent
Pharmacopoeial Discussion Group (PDG)
Based on Pharmacopoeial Requirements
Uniformity of Dosage Units
Disintegration and Dissolution
Hardness or Friability
Water Content
Microbial limits
- includes both the mass of the dosage form and the content of the active substance in the dosage form
- Purpose: To ensure that each unit in a batch should have a drug substance content within a narrow range around the label claim.
- Applies to: Tablet, capsules, granules
Uniformity of Dosage Units
Is defined as the degree of uniformity in the amount of the drug substance among dosage unit.
Uniformity of Dosage Units <905>
is allowed for hard capsules, uncoated tablets, and film–coated tablets containing 25 mg or more of the drug substance comprising 25% or more of the weight of the dosage unit.
Weight Variation
Based on the assay of the individual content of drug substance(s) in several dosage units to determine whether the individual content is within the limits set.
Content Uniformity
Not fewer than 20 dosage units steps:
Weight Variation
Not fewer than 30 dosage units
Content Uniformity
Unless otherwise specified in individual monographs
Specifications
To determine whether the tablet, capsules or granules disintegrate within the prescribed time when placed in liquid medium.
Disintegration
is defined as that state in which any residue of the unit remains on the
screen of the test apparatus or adhering to the lower surface of the disk, if used, is a soft mass
COMPLETE DISINTEGRATION
this test is provided to determine compliance with the dissolution parameters for dosage form administered orally.
Dissolution
Different types of apparatus
Apparatus 1( Basket Apparatus)
Apparatus 2 (Paddle Apparatus)
Apparatus 3 (Reciprocating Cylinder)
Apparatus 4 (Flow-through cell)
Applicable to most tablet, this test supplements other physical strength measurements, such as Hardness Test
Friability
tablets must withstand the rigors of handling and transportation experienced in the manufacturing plant
Hardness (Tablet Breaking Force)
measures the mechanical integrity of the tablet.
BREAKING FORCE
the crushing strength
Hardness
Equipment used for hardness includes:
Stokes Monsanto
Strong-Cobb
Pfizer Hardness Tester
Erweka Tester
Schleuniger tester
- Measured by CALIPER
- ‡5% variation of standard value
- Parts of a CALIPER
THICKNESS (DIAMETER)
