FAST DISSOLUTION RATE POLYMERS
9/24/12: PolyLactic Acid (PLA) Polymers and poly (lactic-co-glycolic acid (PLGA) copolymers are quickly becoming popular materials that carry, deliver, or implant devices into the body. These materials are creating tiny sized camera cases, drug delivery vessels, and dissolving components in a critically controlled timely manner for the treatment of diabetes, cardiovascular disease, glaucoma, COPD, pain management, and many others. These polymers must be compounded and processed in a cost effective way and many of these tiny devices can be manufactured using micro molding or micro insert molding.
The materials must be compounded with pharmaceuticals in some cases, making them even more challenging to process and balance thermal and moisture stable environments to achieve the necessary dissolution rates. These rates vary from 5 minutes to several months, depending on the drug and controlled release timing required for a specific treatment.
Learn more about bio-resorbable polymers by viewing one of our videos called Micro Molding Applications.
A SINGLE DOSE POWDER INHALER IS PILOT-PRODUCTION AND RIPE FOR AN ACTIVE PARTNER TO BRING IT TO MARKET
9/17/12: A single dose powder inhaler is pilot-production and ripe for an active partner to bring it to market.
Introducing DoseOne™, a single dose powder inhaler that is already prototyped, tested, recently benchmarked, and ready for pilot production and a partner to move it forward. The design is SO simple it’s something that makes you say, “Darn, I wish I thought of that, it’s so simple!”
Simple means inexpensive (~$0.30 USD in Full Volume) and fast to market and can be tested in pilot production immediately because it is already designed, molded, and ready for slight modifications to fit a particular size molecule.
Dose-One Patent #7,832,399
DoseOne™ is a single use disposable dry powder inhaler that is:
– Vaccine-ready
– Easy to Carry & package for epidemic/pandemic necessity
– Fills a unique niche in the dry powder inhaler market
Achieves new demanding regulatory requirements previously only achievable using complicated device designs such as:
- Dose counting
- Powder holdup
- Dose readiness indication
- Dose completion / user feedback
DoseOne™ is extremely easy to use and requires minimal training
– The device, as currently designed, requires three steps to use
- Removal from over-pack
- Actuation
- Inspiration
– Actuation is a simple compressive snap
– As a result of it’s simple operation, DoseOne™ has an excellent application in the delivery of drugs (such as vaccinations) to third-world countries
DoseOne™ is currently a three component inhaler with:
- All three components are highly manufacturable.
- Long term material selection which can be determined by the customer as a function of drug chemistry as the device design requires very few material constraints.
- Current performance data which utilized pharmaceutical grade/USP Class VI resins.
Regulatory Advantages:
- DoseOne™ is a single dose device, minimizing dose-to-dose consistency risk.
- No device priming. Many inhalation systems require a prime of the device of a number of shot before use.
- DoseOne™ uses a new device for each dose and thus eliminates the issue of powder “caking and flaking” (deposition during inspiration adding to dose volumes of later doses).
- No dose counting! The FDA and other world health organization strongly recommend the use of dose counters or indicators to increase patient compliance. DoseOne™ is one device, one use, and disposable.
- The current device design contains a very simple dose readiness indicator as well as dose delivery indicator. This comes in the form of a viewing window to allow the user confirmation that the dose is ready, and that the dose has been delivered.
Development Status
- DoseOne has constructed tools for the current DoseOne™designs (Size #2 and Size #4)
- Size #0 and Size #1 design embodiments are tooling kick-off ready. Feasibility, optimization, and DFM details are complete.
- Current single cavity tools are Phase I clinical ready
- Devices are currently in a molded and fully functional state
- US Patents are granted
– US PAT #7,832,399
Partnering Expectations/Goals for DoseOne, LLC:
– Partner with successful formulations development/OEM companies interested in providing patients with effective treatment
– Develop mutually beneficial milestone based license arrangements which results in an expeditious time to market
– Continuously adjust and improve device performance as new formulations become available
– Supply the marketplace with a unique device partnered with an effective drug
Focus groups / Market Studies / Manufacturing Partners
MICRO MEDICAL DEVICES USING ELECTRICAL AND MAGNETIC STIMULATION
9/10/12 Pharmaceutical and medical device companies are expanding into microelectronics for drug delivery and implantable therapies. The value in micro devices are far reaching to treat many chronic debilitating conditions such as muscle stimulation for overworked muscles, transcranial stimulation to alter brain activity, and nerve stimulation for pain management. Micro molding, micro machining, and micro assembly are all enabling manufacturing technologies that integrate microelectronics into polymer and metal components that create the final working and implant-ready devices. Read more on this in a market research company article about micro medical device stimulation here.
MICRO MOLDING NEEDLES AND SHARPS: THE SCIENCE OF COMPLIANCE
9/4/12: Micro molded Needles and Sharps are getting attention these days due to their many advantages including; disposability, recyclability, ease of use, and cost effectiveness. They are being used in applications such as cost-effective vaccine delivery, glucose monitoring and insulin delivery devices, transdermal wearable drug patches, and automatic blister or capsule drug puncturing just to name a few. They are designed and developed in many different forms; transdermal patches, staples, singular needle sites, anchors, forceps, and cannulas. They are manufactured and processed using several micro manufacturing methods; micro molding, micro milling, etching, laser machining, embossing, and forming.
Needle compliance is defined as a needle with the least amount of pain inflicted on the patient AND the ease of use of the device for both patient and surgeon. Compliance can also be taken to the microscopic level as seen in Figure 1.1 which shows the body’s reaction (in this case a cell) to foreign body (the needle) that has been inserted into it. The cell or even the skin will react to the puncture of needles by sending white blood cells to that area immediately as the army of protection comes to the aid of the skin or surrounding cells/organs. This phenomenon is baffling to glucose monitoring device engineers and researchers as these extremely fast responses are measured automatically and in some cases falsely administer insulin unnecessarily.
Figure 1.1 Cellular response of White Blood Cells to Needle Penetrating it (Foreign Body)
In order to provide the least amount of pain to the patient, micro molded needles must be designed and manufactured without a blunt tip which would “drag” the skin and cause pain and prolong puncturing. As is the case with any micro technology (thermoplastic, silicone, or metal), the tooling is THE most critical component to success.
The tooling (see Figure 1.2) for micro molded needles have features in the double digit micron range, there are several challenges that must be overcome to achieve tool to molded needle replication. It is one thing to make nice sharp corners and cavities in steel (less than 1 micron radii) but it quite another to FILL those tiny spaces with polymer. VENTING, VENTING, VENTING: Similar to the real estate sales mantra “location, location, location” it’s all about proper venting and cavity to core fits for the successful degassing of polymer during the ultra-fast injection phase. Proper venting is required. These tiny pockets of steel in the mold leading to atmosphere allow for the flow of polymer to get right to the bottom of the steel cavity thus creating a very sharp point in polymer.
Figure 1.2 Mold Insert and Molded Part on left and Micro Molded Needle Sites with <0.050” (1.3mm) tall needles with 0.002” (50 micron) lumens through each site.
Because needles and sharps can be dust speck in size and require micron level radii to achieve skin, tissue, or organ puncture forces, the tooling or micro mold is the true enabler to their success.