Three types-
1. Primary packaging
2. Secondary packaging
3. Tertiary packaging
Sorption
Leaching
Permeation
Interaction with metals
ABSORPTION + ADSORPTION
The process by which one substance,
such as a solid or liquid, takes up
another substance, such as a liquid or
gas, through minute pores or spaces
between its molecules.
The process by which molecules of a
substance, such as a gas or a liquid,
collect on the surface of another
substance, such as a solid. The
molecules are attracted to the surface
but do not enter the solid's minute
spaces as in absorption.
 Drug or some times excipients can be adsorbed and
then absorbed in the primary packaging. Example-
Packaging Material Incompatible Drug or
Excipients
Glass Proteins,Globulins,Insuline,
Chloroquine
Rubber Antimicrobial preservative
Polyvinyl Chloride
Warferin sodium,
Vitamin A, Benzodiazepines
 Migration of a substance from packaging material into
medicine
Packaging Material Leached substances
Soda glass bottles Alkali substances
Rubber clousures Zinc salts
Borosilicate glass Barium ions
Diethylhexylpthalate
(DEHP)
Calcium ion
 Entry or exit of anything through the packaging
materials.
Packaging Materials Permeated substance
Rubber clousers Water vapour
Polyethylene container Benzyl
alcohol,Chloroxylenol
 Metals are frequently used as constituents of packaging
materials. Depending on the nature of the drug product
this metals reacts with the drug substances.
Reacting metals Incompatible drugs
Heavy metals Bacitracin
Iron, Lead, Barium,
Silver, Manganese
Benzoyates
Mercury Benzalconium Chloride
Aluminium Cisplatin
 Drug – Excipients interaction: Preformulation
stage
 Dosage form – Packaging interaction: After
Preformulation stage
1. Concentration of the reactant
2. pH
3. Ionic strength
4. Temperature
5. Physical state
6. Nature of the materials used in containers and
closures
7. Routs of administration
8. Frequency of dose
9. Clinical uses.
Examinations:
1.TLC (Thin Layer Chromatography)
2.FTIR (Fourier Transform Infrared
Spectroscopy)
3.DSC (Differential Scanning Calorimetry)
4.DTA (Differential Thermal Analysis)
Thank you

Pharmaceutical Packaging incompatibility

  • 2.
    Three types- 1. Primarypackaging 2. Secondary packaging 3. Tertiary packaging
  • 3.
  • 4.
    ABSORPTION + ADSORPTION Theprocess by which one substance, such as a solid or liquid, takes up another substance, such as a liquid or gas, through minute pores or spaces between its molecules. The process by which molecules of a substance, such as a gas or a liquid, collect on the surface of another substance, such as a solid. The molecules are attracted to the surface but do not enter the solid's minute spaces as in absorption.
  • 5.
     Drug orsome times excipients can be adsorbed and then absorbed in the primary packaging. Example- Packaging Material Incompatible Drug or Excipients Glass Proteins,Globulins,Insuline, Chloroquine Rubber Antimicrobial preservative Polyvinyl Chloride Warferin sodium, Vitamin A, Benzodiazepines
  • 6.
     Migration ofa substance from packaging material into medicine Packaging Material Leached substances Soda glass bottles Alkali substances Rubber clousures Zinc salts Borosilicate glass Barium ions Diethylhexylpthalate (DEHP) Calcium ion
  • 7.
     Entry orexit of anything through the packaging materials. Packaging Materials Permeated substance Rubber clousers Water vapour Polyethylene container Benzyl alcohol,Chloroxylenol
  • 8.
     Metals arefrequently used as constituents of packaging materials. Depending on the nature of the drug product this metals reacts with the drug substances. Reacting metals Incompatible drugs Heavy metals Bacitracin Iron, Lead, Barium, Silver, Manganese Benzoyates Mercury Benzalconium Chloride Aluminium Cisplatin
  • 9.
     Drug –Excipients interaction: Preformulation stage  Dosage form – Packaging interaction: After Preformulation stage
  • 10.
    1. Concentration ofthe reactant 2. pH 3. Ionic strength 4. Temperature 5. Physical state 6. Nature of the materials used in containers and closures 7. Routs of administration 8. Frequency of dose 9. Clinical uses.
  • 11.
    Examinations: 1.TLC (Thin LayerChromatography) 2.FTIR (Fourier Transform Infrared Spectroscopy) 3.DSC (Differential Scanning Calorimetry) 4.DTA (Differential Thermal Analysis)
  • 12.