I have been involved in basic research for more than 10 years for innovation of wide range of pharmaceutical products New “Packaging design for Drug delivery” like “Solid doses, Injectables (for anti-cancer, HIV, wide range of vaccines, Covid -19 drugs and Biosimilar products) in “Microgravity Environment like MARS mission.Looking at the presentecological imbalance Scientists are thinking for multiplanetary living system in order tosurvive human species.As we know different planets having critical climatic conditions and Packaging will play a vital role. We as a scientist have clear vision about things are going to happen after 100 years in other planets and from now, we have to keep ready “Packaging designs and delivery systems” for life savings drugs and essential medicines for Astronauts and visitors.

Earth

Mass

Climatic conditions:

Note: Also observed: water,nitrogen oxide, neon,hydrogen-deuterium-oxygen, krypton and xenon

Soil on earth and mars

Wave length

Critical: Parameters: Surface temperature Atmospheric pressure Atmospheric composition Carbon/oxygen cycles Nitrogen cycles Magnetic fields achieve temperatures and pressures similarto standard atmospheric temperature and pressure here on Earth.

Pharmaceutical PlantDesign for MARS

Drug Delivery Device

Application Methods:

1. Draw up the drug by the needle from the vial with the piece labeled“1” and lock it in place by rotating it to the side.
2. Load the spring by pulling both bars labeled“2” into the slots at the end.
3. Before administrate the drug, press the device against your leg or arm and release the bars from the slots. This will release the spring and simultaneously push the needle into the body and inject the medication. The device and the containershould be printedout of plastic, and the needle shouldbe printed from stainless steel.It is designed for both the microgravity trip and the one-thirdgravity of Mars.

High radiation in Microgravity and Packagingsolutions

Tablet/capsule Dispensing (Manual operation) 

Packaging for Solid Doses products (Microgravity)

Recommendations:

1. In order to avoid extremeheat and radiationbetter to use “Multilayer bottles(black coating inside)
2. Outside and inside “Black ink (food grade) layer need to use.

Packaging for “Injectables” (Microgravity)

Recommendations:

1. Outer surface of the “Vial,PFS and cartridges” should be “Lacquerwith gold ink”
2. You can go for “black /gold lacquering”.

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2

Bubble Free Injection Syringein Space a Big Challenge

• During or before administration on Earth we are rarely facing “Air bubble “formationinside the syringe.Whereas on MARS i t’s common due to low gravity.
• A singleair bubble into a crewmember is harmful.

Air bubble

Applied “Electromagnetic field” inside the “Auto injector” to infuse the Air bubbles.We can avoid delamination insidethe syringe if we use following:

1. Plunger innersurface can be coated with “Silicon oil”
2. Change of “Sterilization process”
3. Can be use COC/COPsyringes.
4. Possible to use “Fluoropolymer coating” inside the syringe surface.
5. Rectification of product formulation i.e reduce Ph of the product if possible.

Extractable and leachable are most important for inhalers and catheters.For an extractables from a device component the AET (μg/g) can be determined using Equation 1:Equation 1

AET = SCT. Dt

Dd m

Dd- Doses per day

Dt- Total Labelleddoses

m - mass of component

The AET (μg/device) for a drug delivery device (e.g. an MDI) can be determined from Equation 2: AET = SCT .Dt

Dd

Dd- Doses per day

Dt- Total Labelleddoses

Delamination of Glass, inhalerand catheters

There are many cases we observed Astronauts are facing breathing problems, so this is advisable they should carry sufficient numbers of “Inhalers”. Packaging technologists are playing major role for selection of primary packing materials, designing and final packing.

We should be very much carefulto avoid corrotion, leakage, extractable & leachables. Better not to use any coloured lacquersinside surface of the “Inhalercylinder. Design has to be validated.

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As you know due to extreme heat and radiation “Fluid of eyes” get dries, so Astronauts need to carry “eye ointments” those should have single dose” and make sure 100% product will come out in one press. Recommendto use “LDPE or LLDPE” for primary packaging materials.One strip shouldcontain 5 tubes and should be vacuumpacked.

Fluid of eyes

Burning skin is the most common thing in Microgravity environment. So, Astronauts and visitorshave to carry sufficient numbersof this item. This has to keep in a cool place and packed in a “Gold lacquered” Tin or Aluminium box.

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Chemical Structure of Nitrocellulose

A & B

Risk Ratings and Dispositions per Design Reference Mission (DRM) Category

Medical device Regulations for space (Drafting is going on) Medicaldevice safety

• Medical devicesafety and risk management
• Effectiveness/performance of medical devices
• Phases in the life span of a medicaldevice
• Participants in ensuring the safety of medical devices
• The role of each participant/stakeholder
• Shared responsibility for medical device safetyand performance

Governmental regulation of medical devices

• Critical elementsfor regulatory attention
• Stages of regulatory control
• A commonframework for medicaldevice regulations
• Regulatory tools and generalrequirements
• Product control
• Vendor establishment control
• Post-market surveillance/vigilance
• Quality systemrequirements