Requirements for drug packaging

2022-06-22
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Requirements for drug packaging

1 The properties specially required in the drug packaging are:

◆ protection

a mechanical strength: impact strength, compression, tensile strength, rupture strength

b isolation: moisture resistance, gas barrier, shading, fragrance retention

c stability: high temperature resistance, light resistance, cold resistance, chemical corrosion resistance, aging resistance

◆ safety and health - no harmful substances and toxic additives, no impurities

◆ non reactivity - no reaction or absorption with the internal reagent

◆ operability - suitable for packaging equipment processing

◆ simplicity - easy to open

◆ merchantability - transparency and gloss

◆ easy to discard - reduced volume and good environmental protection

◆ economic benefit - production efficiency, low cost of packaging base materials

some medical drugs require a five-year guarantee period, especially for drugs that are moisture-absorbing or easily deteriorated by oxidation, the packaging is required to have a high barrier. However, the difference between 0cc/m2 and 1cc/m2 in oxygen barrier property is very different within 5 years, which leads to problems. If there is no change between 0CC and 1cc, it is necessary to require a high barrier packaging substrate, which is basically composed of aluminum foil

2. Problems needing special attention in drug packaging:

1) prevent impurities from mixing: the so-called impurities refer to insects, hair, adherent foreign matters, dirt mixing, material debris, etc

2) odor prevention: no odor of printing ink, adhesive residual solvent and sealing layer is allowed

3. Composition of drug packaging base material:

1) 3 The transmitter wiring is incorrect. The composition of powder packaging base material: it is classified according to the grade of moisture absorption and shading of the powder (granular)

2) pill packaging: in the past, SP packaging and PTP packaging were mostly used for pills, but recently more than 80% of them were PTP packaging. In addition, the centralized packaging methods of SP and PTP are:

a. PE light film (70-100) with low barrier requirements μ m)

b. medium barrier requirements: pet/pe/al/pe/, kop/pe, dpet/pe

c. high barrier requirements: pet/pe/al/pe (can also use desiccant)

4 Change of composition of drug packaging base materials

when changing the composition of new base materials, it is necessary to evaluate the function of the packaging base materials, and check the reactivity with the drug and the absorption of the drug (the composition of the absorbent of the heat sealing layer)

1) evaluation of barrier property: it must be at 40 ℃ × Accelerated test at 75%rh for 6 months. Because such a time-consuming test must be carried out, the change of other substrates to replace the current aluminum foil structure is slow

2) application to the health department: when changing the packaging composition, data must be collected and applied to the health department for approval

5. Base material composition of current products

generally, the packaging base material composition of small packages of drugs is pt/pe/al/pe or pet/pe/al/pe. The small package shall be moisture-proof and slitting, and Pt (MST) materials shall be used. As a special structure, there is "pabron s" (drug) of Dazheng pharmaceutical company

composition: pet (12 μ m) - ink//al (9 μ m)/while maintaining the toughness of the material/pan (30 μ m) (size 50 × 70mm。 Pan (polyacrylonitrile resin) is used as the heat sealing layer in this composition. Pan can directly contact with food, and as the packaging base material of cosmetics, drugs and medical devices, it is suitable for health requirements. It has chemical corrosion resistance, gas barrier and fragrance retention. While PE material will absorb some specific components of the agent, pan does not absorb components and is easy to heat seal. (luoxiaoming) (print weekly)

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