Pharmaceutical Packaging: “Pharmaceuticalpackaging means the combination of components necessary to contain, preserve,protect & deliver a safe, efficacious drug product, such that at any timepoint before expiration date of the drug product, a safe & efficaciousdosage form is available”.Types of Packaging Systems: Primary package system:· Made up of those packagecomponents & subcomponents that come into direct contact with the product,or those that may have a direct effect on the product shelf life. Secondary or tertiarypackage system: · Includes cartons, corrugatedshippers & pallets.Packaging must meet the following Requirements: idealrequirements· Protect the preparation fromenvironmental conditions.
· Non-reactive with theproduct and so does not alter the identity of the product.· Does not impart tastes orodors to the product.· Nontoxic.· FDA approved.· Protect the dosage form fromdamage or breakage.
· Meet tamper-resistance requirements,wherever applicable 1. Packaging materials & closures: lnjectable formulations are packaged into containers made of glassor plastic. Container systems include: · Ampoules, · Vials, · Syringes, · Cartridges, · Bottles, and · Bags 2.
TYPES OF GLASS · Type I – Borosilicate Glass · Type II – Treated Soda-LimeGlass · Type III – Regular Soda-LimeGlass · Type NP – General PurposeSoda-Lime GlassType I: Borosilicate Glass · Highly resistant glass· A substantial part of thealkali & earth cations are replaced by boron and/or aluminum & zinc. · It is more chemically inertthan the soda-lime glass. · It is used to contain strongacids & alkalies as well as all types of solvents. · The addition of approx 6%boron to form type I glass reduces the leaching action.Type II: Treated Soda-Lime Glass · Type II containers are madeof commercial soda-lime glass that has been de-alkalized or treated to removesurface alkali.· The de-alkalizing process isknown as “sulfur treatment” and virtually prevents “weathering” of emptybottles.· Thus sulfur treatmentneutralizes the alkaline oxides on the surface & thus rendering the glass more chemically resistant.
Type III – Regular Soda-Lime Glass· Containers are untreated& made up of commercial soda-lime glass of average or better than-averagechemical resistance.Type NP – General Purpose Soda-Lime Glass· Containers made up ofsoda-lime glass are supplied for non-parenteral products, those intended fororal or topical use.PLASTIC CONTAINERS: Advantages: · Ease of manufacturing · Available in various typesof quality · Freedom of design to whichthey lend themselves · Extremely resistant tobreakageDosage Form – Plastic Interactions / Limitations of PlasticMaterials: · Permeation · Leaching · Sorption · Chemical modification · Alteration on the propertiesof plastics or product 1.
TYPES OF CONTAINERSInjections are placed either in single-dose containers or inmultiple-dose containers. o Single-dosecontainer: · A hermetic container holdinga quantity of sterile drug intended for parenteral administration as a single dose;when opened, it cannot be resealed with assurance that sterility has been maintained.o Multiple-dosecontainer: · A hermetic container thatpermits withdrawal of successive portions of the contents without changing the strength,quality, or purity of the remaining portion 3.Ampoules· Small-volume parenteralproducts are often packaged in glass or plastic ampoules.· Ampoules are used for singleuse, unpreserved products. · Glass ampoules range in sizetypically from 1 mL up to 10 mL in volume, though larger sizes are available. · The glass chosen is referredto as Type I or borosilicate glass.
· Ampoules are supplied as opennecked containers that are sealed by fusion of the narrow glass neck after filling.· Usually the neck of theampoule has a painted ceramic ring on it. Due to the baking process required tofuse the ceramic to the glass, this acts as a weak point at which the ampoulecan be easily snapped open by hand. Advantages · Glass ampoules are lowcost and · Very little interactionbetween the container and the product (if Type I glass is used). Disadvantages· Fragility glass container.· Potential for deposition ofglass particles into the drug product on opening.· Potential for injury to the fingersof the person opening the ampoule. .
Vials· Vials are containersusually made of Type I borosilicate glass. · With a re-usable syntheticrubber closure. · Vials have advantages ascontainers as they permit multiple withdrawals. · Made in sizes usually rangingfrom 5 mL to 100 mL.
· Vials are sealed with a bromobutyl or chlorobutyl synthetic rubber closure held in place by an aluminiumseal crimped around the neck of the glass vial. · Rubber closure (or septum)is usually protected by a plastic flip-off cap. · Rubber septum isself-sealing to a high degree and so more than one withdrawal can be made froma vial. · Products packaged in vialsfor multiple use will therefore incorporate a preservative to prevent anymicroorganisms accidentally introduced into the product during use fromproliferating.Advantage:· The glass is inert anddoes not interact with the drug.Disadvantage: · Puncturing the rubberclosure can cause large rubber particles to be introduced into the drug product.
Infusion bags and bottles· Large volume parenteralproducts are packaged in glass bottles, collapsible plastic bags and semi-rigidplastic bottles.· These products range insize from 100 mL up to 1000 mL.· Collapsible bagpresentations are the most common form of container. · They are manufactured fromPVC or more increasingly polyolefin plastic. · Collapsible bags usuallyhave an additive port to allow other injectable drugs to be added to theinfusion fluid. · Polyolefin is much lessreactive and is now replacing PVC for this reason in infusion bags.
· Large volume glass bottlesare essentially the same as glass vials, but on a larger scale. · All large volumeparenteral products are meant for single-use only. Advantages:· Collapsible bags is that theycollapse under atmospheric pressure as the contents are removed from them.· Therefore they do notrequire an air inlet system to equilibrate air pressure between the outside andinside of the container, as do rigid glass bottles. Disadvantages: · PVC bags is that drugs maybecome adsorbed onto the plastic (e.g.
insulin) or react with the plastic (e.g.etoposide). · Components can leach outof the plastic such as monomers and phthalate plasticizers which may be toxicin long-term exposure.
Syringes· Nowadays, parenteralproducts may be packaged in syringes.· Thus be presented to thehealthcare professional or patient in a ready to use format. · This requires aseptic fillingusing specialist equipment.· Drug can be administeredfrom the syringe using an infusion device 4.