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level: PACKAGING MATERIALS 2

Questions and Answers List

Drug Plastic Considerations

level questions: PACKAGING MATERIALS 2

QuestionAnswer
A packaging system must protect the drug without altering the composition of the product until the last dose is removed.DRUG-PLASTIC CONSIDERATIONS
Drug-plastic considerations five categories:1. Permeation 2. Leaching 3. Sorption 4. Chemical Reaction 5. Alteration
It is the transmission of gases, vapors or liquids through plastic packaging material.Permeation
1 In Permeation, major problem is when dosage form is sensitive to __ 2 In Permeation, __ might change when stored in plastic containers and the __ may change.1 hydrolysis and oxidation 2 volatile ingredients, taste of the medicinal products
Some plastic containers have one or more ingredients added to stabilize it, these may leach into the drug product.Leaching
1 In Leaching, Problems may arise with plastics when __ are added in small quantities to the formula. 2 In Leaching, Particular __ may migrate into the parental solution and cause a __ effect.1 coloring agents 2 dyes, toxic
Removal of constituents from the drug product by the packaging material.Sorption
What are the problems pose by Sorption in products?1 Reduced therapeutic efficacy 2 Changes in the chemical structure, pH, solvent system, concentration of active ingredients and temperature etc…
Certain ingredients in plastic formulations may react chemically with one or more components of the drug product. In micro quantities if incompatibility occurs may alter the appearance of the plastic or the drug product.Chemical reactivity
1 It is the physical and chemical alteration of the packaging material by the drug product 2 Some __ can have considerable changes in the mechanical properties of the plastics.1 Modification 2 solvent systems Ex. oils have a softening effect on polyethylene, hydrocarbons attack polyethylene and PVC.