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Abstract

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 present ecological imbalance Scientists are thinking for multiplanetary living system in order to survive 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.

Mars Vs Earth Comparisons

Figure1: Earth

Figure 2: Mars

Table 1: Climatic conditions
Note: Also observed: water,nitrogen oxide, neon,hydrogen-deuterium-oxygen, krypton and xenon

Table 2: Soil on earth and mars

Figure 3: 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.

Figure 4: Pharmaceutical Plant Design for MARS

Figure 5: 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 container should be printed out of plastic, and the needle should be printed from stainless steel. It is designed for both the microgravity trip and the one-third gravity of Mars.

Figure 6: High radiation In Microgravity and Packaging solutions

Figure 7: Tablet/capsule Dispensing (Manual operation)

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.

Figure 8: Packaging for Solid Doses products (Microgravity)
 

Packaging for “Injectables” (Microgravity)

Recommendations:

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

Figure 9: Packaging for “Injectables” (Microgravity)

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 single air bubble into a crewmember is harmful.

Figure 10: Air bubble

Recommendation
Applied “Electromagnetic field” inside the “Auto injector” to infuse the Air bubbles. We can avoid delamination inside the syringe if we use following:
Plunger inner surface can be coated with “Silicon oil”
Change of “Sterilization process”
Can be use COC/COP syringes.
Possible to use “Fluoropolymer coating” inside the syringe surface.
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 Labelle doses
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 Labelle doses

Delamination of Glass, inhaler and 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.

Figure 11: Delamination of Glass, inhaler and catheters

Eye ointments Packaging
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. Recommend to use “LDPE or LLDPE” for primary packaging materials. One strip should contain 5 tubes and should be vacuum-packed.

Figure 12: Fluid of eyes

Nitrocellulose patches Packaging
Burning skin is the most common thing in Microgravity environment. So, Astronauts and visitors have to carry sufficient numbers of this item. This has to keep in a cool place and packed in a “Gold lacquered” Tin or Aluminum box.
 

Figure 13: Chemical Structure of Nitrocellulose

Figure14(A&B): Wet & Dry

Table 3: Risk Ratings and Dispositions per Design Reference Mission (DRM) Category

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

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

Governmental regulation of medical devices

• Critical elements for regulatory attention
• Stages of regulatory control
• A common framework for medical device regulations
• Regulatory tools and general requirements
• Product control
• Vendor establishment control
• Post-market surveillance/vigilance
• Quality system requirements
   

References

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2. NASA Technology Transfer Program on twitter @NASAsolutions.
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3. Handheld Diagnostic Device Delivers Quick Medical Readings.
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