frontida | white paper adaptdose · 2020. 11. 13. · oral dosage form manufacturing and packaging...

FRONTIDA | WHITE PAPER . ADAPTDOSETM

ADAPTDOSE TM

AN INNOVATIVE PLATFORM THAT REDUCES PRODUCTDEVELOPMENT TIME AND COST BY 30% OR MORE

FRONTIDA | WHITE PAPER . ADAPTDOSE®

RON CONNOLLYCOFOUNDER & EVP, BD, ALLIANCES AND REGULATORY AFFAIRS

FRONTIDA BIOPHARM, INC.

JANUARY 01, 2017

ABSTRACT

CONTENT SECTIONS

CONTRACT MANUFACTURING

Oral dosage form manufacturing and packaging of immediate release and controlled release tablets, capsules, powders, liquids and suspensions.

Our experienced team employs multiple oral drug delivery systems and Quality by Design to achieve the target. Focused on Highly Potent, DEA-controlled or difficult to formulate products.

Fully staffed raw material and commercial product release GMP laboratories ready to support your development, stability and manufacturing projects.

PRODUCTDEVELOPMENT

ANALYTICALSERVICES

0102030405060708

SECTION 01

ADAPTDOSETM: REDUCING PRODUCTION TIME AND COSTS

02FRONTIDA | WHITE PAPER . ADAPTDOSETM

ABSTRACT (cont’d)SECTION 01


WRITTEN BY: DATE:

JANUARY 01, 2017

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Are you searching for ways to get your product into clinical trials faster?

Do you believe that you are wasting R&D resources at earlier stages of development by making customized dosage forms for a specific clinical study that may never be used for a commercial product?

Are you trying to formulate combination products with known chemical interactions?

Frontida has a solution that increases the probability of utilizing the know-how of early formulation efforts in later stages of development.

Using our innovative capsule-filling equipment and processing technology, plus mini-tablet and drug-layered beadlet manufacturing capabilities, Frontida can provide an adaptable, easily modified formulation even before knowing the therapeutic dose of your investigational new drug.

Contact us to find our more about our adaptive formulation technology.

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Considering the effort required to bring new products to market, drug development scientists have significant concerns in balancing the development of robust formulations, costs and time to clinical studies at earlier stages of clinical research. A common approach to try to limit the expenses of formulation development at Phase I and II is to create a simple oral liquid, API powder in capsule or powder for constitution or injection. These formulations are often limited in stability or present challenges for bioavailability for the API. As a result, companies will develop another formulation for Phase II or III studies and commercial launch that have the desired dose, stability and enhanced bioavailability.

Frontida’s AdaptDoseTM technology platform provides a tool that can eliminate the need to reformulate after Phase I and overcomes several technical hurdles in the development and scale up of (1) new molecules, (2) binary and tertiary mixtures of active ingredients, zero and first order drug release matrices or (3) scalable clinical trial materials used in dose-ranging or adaptive dose clinical studies. AdaptDoseTM technology allows us to incorporate granules, beadlets/pellets and mini-tablets into a single capsule without the step of mixing different materials prior to filling, using our commercially engineered, accurate and high speed equipment (capable of fill speeds over 100,000 units per hour.)

Let’s take a look at three common formulation challenges and how AdaptDoseTM can be used to overcome these challenges.

INTRODUCTION


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PROBLEM 01

Answer:

Benefits:

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You are entering a new drug candidate into clinical development, but you are uncertain of your target exposure levels for the study. Do you resort to API powder-in-a-capsule, knowing that you need a viable product formulation shortly after your dose escalation studies?

Frontida’s formulation development team has successfully developed the use of mini-tablets as a streamlined, flexible oral solid dose platform that we call AdaptDoseTM. Using this technology, we can develop a stable tablet formulation that is pressed into mini-tablets measuring 1.0 millimeter to 2.5 millimeters in size. We then utilize our uniquely engineered capsule-filling equipment (equipped with visual and weight inspection systems) to precisely load the correct dose of mini-tablets into a single dose capsule. This technology enables us to quickly deliver customized doses of your investigational new drug for adaptive-design clinical studies, such as Dose Range Finding and Dose Escalation Studies at Phase I and II of clinical development. When the target doses are identified from the clinical research, Frontida’s team can then utilize the already-developed formulation to efficiently create larger tablets of the target dosage strengths for Clinical Phase III and commercial production.

Frontida’s AdaptDoseTM technology eliminates the necessity of using an early-phase powder formulation and corresponding stability data, that may result in limited utility for the product’s lifecycle, saving tens of thousands of dollars and months of development effort. Mini-tablet technology allows us to create a variety of strengths required for clinical dose escalations (SAD and MAD studies) of the product, in a format that can be used in future development efforts and clinical phases. You can then gain valuable know-how about the stability and utility of a tablet formulation for future efforts.


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PROBLEM 02

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Answer:

Benefits:

You have interest in developing a fixed-dose combination (FDC) of 2 or 3 Active Pharmaceutical Ingredients (APIs) for oral delivery, but are aware of a potential chemical interaction between the API’s. How can you develop a combination that avoids the interaction issue?

AdaptDoseTM gives Frontida the ability to accurately combine multiple active ingredients into one capsule while avoiding the potential for interactions. How can we do so? By creating independent, single-API formulations with a protective barrier that can reduce the potential for interaction when the formulations are combined in a single unit dose. Because our capsule-filling technology platform shortcuts the need to blend the formulations together prior to filling, we can quickly and successfully develop FDC products.

Frontida’s AdaptDoseTM technology serves as a platform to bring fixed Dose Combinations to clinical studies and the market. The platform is so flexible that both small, clinical trial material batches and large, commercial-scale production can be produced in the same equipment, reducing the amount of manufacturing studies and process validation efforts required. Once the clinical trials prove the combination to be effective, our clients can quickly launch the FDC product upon FDA approval, saving months, if not years of process development and stability study efforts.


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PROBLEM 03

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Answer:

Benefits:

You want to combine different release mechanisms into one dosage unit in order to provide the benefits of a dual release system with the simplicity of one dosage unit.

Do you resort to bi-layered tablets which eliminate the advantages of a multi-particulate capsule system while presenting manufacturing challenges due to the bi-layer compression process?

Do you resort to administering two capsules, each separtely filled with different beads, which may result in decreasing patient compliance?

Using AdaptDoseTM, we can design a combination of mini-tablets, beads, granules or liquid with different release mechanisms, such as immediate-release, extended-release or delayed-release into one dosage unit. The technology allows us to quickly create a combination of quick onset of action and/or extended or delayed therapeutic effect. The combination can be in any ratio to achieve the desired release profile with our uniquely engineered capsule filling equipment and processing technology. Furthermore, certain types of matrix that we can employ in this sytem can provide both immediate and delayed action, resulting in operational efficiencies and reduced costs.

Frontida’s AdaptDoseTM technology enables us to quickly deliver customized release profiles which can be used in clinical studies to validate delivery systems that can provide therapeutic doses over 24 hours and improve patient compliance. The release profiles can be easily modified based on the outcomes of the pharmacokinetic and therapeutic effects observed in the trial.

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CONCLUSION

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As demonstrated by these three scenarios, AdaptDoseTM can serve as a unique, commercial-ready technology that allows our clients to quickly create custom oral delivery systems, thereby reducing the time to market, improving the flexibility of system modifications during clinical studies and decreasing the potential need to reformulate the product. It is a platform that can also help companies bring new Fixed Dose Combinations to clinical research and commercial.

If you wish to speak further about your specific application, our team would be happy to arrange a free consultation to determine if your product concept fits the AdaptDoseTM platform. Contact us at the number listed in the Contact Information section below, or use our online form to arrange a consultation.

Mini-TabsGranules/Beads

Powders

Combinationdelivery in Capsules


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ABOUT FRONTIDA

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Frontida BioPharm, Inc. is a US-based, minority-owned leading provider of drug delivery technologies, product development, and manufacturing services for pharmaceutical and consumer health companies. Frontida is dedicated to helping our clients and partners reach the market as quickly and efficiently as possible. We support pharmaceutical companies in the development, scale-up and commercial manufacturing of immediate and controlled-release oral solid dose, powder and liquid products; ensuring robust product performance and on-time supply of clinical trial materials and commercial products. Our 325,000+ sq. ft. manufacturing facilities located in Philadelphia, PA and Aurora, IL offer a comprehensive suite of solutions for the development and commercialization of prescriptions, OTC, Highly Potent Active Ingredient (HPAI) products, Phase I through Phase III clinical trial materials, Fixed-dose Combination Products and DEA schedule II–V products. Frontida is equipped with multiple world-class commercial packaging lines, capable of validated product serialization, and providing packaging services for both commercial products and clinical trial material supplies in bottles and blisters. Frontida has an annual capacity to manufacture up to 3 billion tablets and capsules. Our highly experienced industry-leading team of professionals offers a number of available technologies and solutions that facilitate the commercialization of high-quality products.


CONTACT INFORMATION

WEBSITEFRONTIDA.COM

FRONTIDA BUSINESSDEVELOPMENT+1 (215) 807-1350

FOR MORE INFORMATION, PLEASE CONTACT FRONTIDA BELOW.

FRONTIDA EMAIL

PHILADELPHIA, PA

FRONTIDA BIOPHARM, INC.1100 ORTHODOX STREETPHILADELPHIA, PA 19124

PHONE NUMBER+1 (215) 288- 6500

AURORA, IL

2500 MOLITOR ROADAURORA, IL 60502

PHONE NUMBER+1 (630) 888-3820

OFFICE LOCATIONS


https://www.frontidabiopharm.com/

mailto:[email protected]

FRONTIDA | WHITE PAPER . ADAPTDOSE®

ADAPTDOSE TM

AN INNOVATIVE PLATFORM THAT REDUCES PRODUCTDEVELOPMENT TIME AND COST BY 30% OR MORE



FRONTIDA BIOPHARM, INC.

JANUARY 01, 2017

frontida | white paper adaptdose · 2020. 11. 13. · oral dosage form manufacturing and packaging...

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