dosage form and material (ours)[1]

8/8/2019 Dosage Form and Material (Ours)[1]

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Protect against all adverse external

influences

that can alter the properties of the product.

Protect against biological contamination.

Protect against physical damage.

Carry the correct information and

identification

of the product.

Tamper evident / Child resistance

/ Anti counterfeiting.


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Primary packaging is the material that firstenvelops the product and holds it. This usually is the

smallest unit of distribution or use and is the

package which is in direct contact with the contents.


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Secondary packaging is outside the primary

packaging perhaps used to group primarypackages together

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Tertiary packaging is used for bulk handling ,

warehouse storage and transport shipping.

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Ampoules

Vials

Containers

Dosing dropper

Closures (plastic, metal)

Syringe Strip package

Blister packaging

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Paper and boards

Cartons

Corrugated fibers

Box manufacture

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SECONDARYPACKAGING MATERIALS

PAPER:-

Used as a flexible wrap for products, or as a closure

material for jars. Most paper materials are used witha liner applied either as a laminate or as a coating.

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PHARMACEUTICALCORRUGATED

FIBERBOARD

Corrugated fiberboard is a paper-based construction

material consisting of a fluted corrugated sheet and

one or two flat linerboards.

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Dosage form

Route of administration

Stability of the API

Protection Single-use or multi-use

Storage

Transport

Mode of sale and marketing Patients convenience

Identification

Environmental concerns

Cost


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Types of glass

NP (non parenteral) General purpose soda lime glass .

Coloured glass Addition of metal salts.

Neutral glass Its composition is between soda lime and

borosilicate glass.

Type General description

I Borosilicate glass

II Treated (dealkalized)soda lime glass

III Regular soda lime glass


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High compression strength

Material strength to permit hot filling and retorting

Heat resistance

Impermeable to gases

Inert Clarity

Easily cleaned and sterilized

Fabricated into multiple sizes and shapes

Mature technology

Acceptance by consumers Widespread availability


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High density

Brittleness

More costly


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Type of glass containers

Parenteral bottles

Dropper bottles

Jars

Ampoules

Viales


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Ti l t

l i i i


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Advantages of metal as packaging

mater

ialo Material strengtho Shatterproofo Impermeable to gaseso Light barriero Lightweighto Malleabilityo Exterior decorationo Tamper evidence


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D

isadv

antages Potential interaction with product

Limited shelf life

High production cost


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steel coated with a thin deposit of tin on the

surface of a sheet of steel

Applications:

Aerosol Topical ointment


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Applications: Cans

Closures (metal can

ends)

Tubes Pouches

Foils


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1. l t l

2. l r l

3. l vi l l ri ( V )

4. l st r


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A type of polymer

Can be linear/branched

Can be homopolymer/copolymer

Can be generally divided to thermoplasticand thermosets


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The final product can flow without chemicialchange.

Maintain the ability to melt at elevated

temperature

Can be shaped multiple times in the presence ofheat and mechanical force

Eg of thermoplastic classes

Amorphous materialsP C

CrystallinePE (HDPE)


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Consumer preference for plastic

Lighter

Shatterproof

Clear and opaque Heat sealing

Decoration

Thin films with high strength and toughness

Easy handling Design freedom

Potential of lower cost


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Chemical inertness

Stress cracking

Low resistance to heatL

ow resistance to lightLow resistance to oxygen

Leaching of low-molecular-weight polymerfragments by a drug or solvent


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1. l t l

2. l r l

3. l vi l l ri ( V )

4. l st r


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HDPE medicine bottle


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LDPE medicine bottle LDPE as

laminate of

aluminium foil


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LLDPE medicine bottle


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Permeable to oxygen

Poor odor barrier

High permeability to halogens

Oil softening

Permeability

Poor resistance to strong oxidizing acids

Sorb other materials


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resistant to higher temperatures

better resistance to grease and oil

better odor barrier

fewer tendencies to absorb certainingredients

used in thermoformed trays and blowmolded bottles for drug, films andblister packaging


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used in I bags to

replace glass bottles for

blood products and for

I glucose and salinesolutions

also used for blister

packs and bottles


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Advantages

-High flexural strength

-Chemical resistance

-Low permeability to oils, fats, and flavorings-Easy coloring or tinting

-Low cost

-Presents a glossier appearance on the store

shelf that is appealing to consumers


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Disadvantages

-wide array of additives used to modify the

properties of the finished plastic such as

plasticizers and lubricants-burning of P C materials produce HCl gas which

is toxic to the environment


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used with bottles for tablets and capsules

clear and rigid at normal temperature

softens at relatively low temperatures

poor gas barrier

Environmental unfriendly


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Tablets and capsules


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Liquid dosage forms


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Parenteral dosage forms

dosage form and material (ours)[1]

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