*Corresponding author: *Anupam Chanda, M.Sc Packaging and Polymer Science, Bioxytran Inc, Boston,USA
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.
INTRODUCTION
MARS VS EARTH COMPARISONS
Critical: Parameters: Surface temperature• Atmospheric pressure• Atmospheric composition• Carbon/oxygen cycles• Nitrogen cycles• Magnetic fields• achieve temperatures and pressures similar to standard atmospheric temperature and pressure here on Earth.
Pharmaceutical Plant Design for MARS
How Injectable device will work in MARS
High radiation in Microgravity and Packaging solutions
Tablet/capsule Dispensing(Manual operation)
Packaging for Solid Doses products( Microgravity)
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.
Recommendations:
1) In order to avoid extreme heat and radiation better to use “ Multilayer bottles ( black coating inside)
2) Out side 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 “ Lacquer with gold ink”
2) You can go for “ black /gold lacquering”.
Bubble Free Injection Syringe in Space a Big Challenge
1. During or before administration on Earth we are rarely facing “ Air bubble “ formation inside the syringe. Where as on MARS it’s common due to low gravity.
2. A single air bubble into a crewmember is harmful
Recommendation: Applied “ Electromagnetic field” inside the “ Auto injector” to infuse the Air bubbles.
We can avoid delamination inside the syringe if we use following:
1) Plunger inner surface can be coated with “ Silicon oil”
2) Change of “ Sterilization process”
3) Can be use COC/COP syringes.
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 Labelled 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 Labelled 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 careful to avoid corrotion , leakage, extractable & leachables. Better not to use any coloured lacquers inside surface of the “ Inhaler cylinder. Design has to be validated.
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.
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 Aluminium box.
Chemical Structure of Nitrocellulose
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
Author’s Detail
Anupam Chanda has his expertise in creating innovative design in packaging material and device for Biologics, Biosimilars , anti Cancer and HIV products. He is having approx three decades( approx. 30 years) of experience in India and abroad. He is a renowned international speaker, travelling frequently in USA, Europe and Japan for research and consultation purposes. Gain and share his thoughts with scientist from various institution and industry professionals. Author’s Technical book “ Packaging Technology An advance Practical approach, Packaging challenges for Microgravity and Regulatory observations and style of responses. “Published from Germany and Amazon is distributing to 77 countries. Packaging challenges for Microgravity Book considered as a reference book in “ Harvard university , USA and “ Packaging Technology An advance Practical Approach” book is going to consider as a text book for M.Sc and M.Tech Packaging Technology in IIP and IIT Roorkee, India. These books are available in www.amazon. de, www.amazon.com and www.morebooks.de. He is attached with various charitable institutions and research institutes. Mail: mr.anupamchanda@rediffmail.com
References
- Humans in Space, International Space Station (ISS), Space Station Research and Technology
- NASA Technology Transfer Program on twitter @NASAsolutions
- Handheld Diagnostic Device Delivers Quick Medical Readings
