Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 149.22K | Year: 2012
Combat ration Intermediate Moisture (IM) products use low pH and water content (aw) to discourage bacterial growth. The long-term goal of this proposal is to maintain the microbial stability of ration components over a two-year shelf life while increasing the pH and aw values for an improved organoleptic profile. The specific objective of this Phase I application is to develop microspheres for continuous, controlled-release of Nisaplin over a two-year period using Orbis"Precision Particle Fabrication (PPF) microsphere encapsulation technology. The incorporation of this time-released system in addition to a one-time injection during initial packaging would allow for higher pH and aw thresholds, providing a safe, high-quality ration platform with improved palatability. First, uniform, Nisaplin-loaded microspheres with three different diameters will be formulated to characterize in vitro release kinetics. Second, through in vitro release testing, the formulation of Nisaplin-loaded microspheres will be optimized to achieve sustained, two-year Nisaplin release. In the Phase I Option, the controlled-release system will be compared to single-dose delivery. The central hypothesis is that uniform, Nisaplin-loaded PPF microspheres will offer a cost- and dose-effective food preservation system with precisely tailored anti-microbial release characteristics to effectively inhibit gram-positive pathogens over the two year shelf-life of the food product.
Orbis Biosciences, Inc. | Date: 2014-06-12
Particles for delivery of active ingredients formed from an active ingredient and a hydrophobic matrix, as well as methods for making such particles.
Orbis Biosciences, Inc. | Date: 2016-08-23
The present disclosure relates to a taste-masking microcapsule composition. The composition comprises a core portion encapsulated by a shell portion. The core portion comprises an active pharmaceutical ingredient (API) and one or more excipients. The shell portion comprises a hydrophobic matrix and a pH-responsive material. The microcapsule compositions prevent API release at the more neutral pH levels in the oral cavity, but upon exposure to pH levels of the stomach, the pH-responsive material becomes soluble thereby permitting release of the API.
Orbis Biosciences, Inc. | Date: 2015-06-12
An extended-release drug delivery composition and method of administering the same is provided. The composition comprises microspheres loaded with a biologically-active agent and suspended in a soluble polymer capable of forming a film upon injection onto a biological surface.
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.70M | Year: 2013
DESCRIPTION provided by applicant A critical need currently exists in the pharmaceutical market for microparticles that can accurately and effectively control the release of poorly water soluble compounds Although these poorly water soluble drugs are projected to have high clinical efficacy they are often rejected in the early stages of research because of the high cost and technical difficulties of formulating and delivering molecules with poor water solubility Orbis Biosciencesandapos novel Precision Particle Fabrication PPF technology has the potential to address this drug formulation dilemma by allowing flexible cost effective single step encapsulation of poorly water soluble drugs while also providing precise control over particle size shape composition and release profiles Our long term goal is the application of a commercial scale multi nozzle PPF system for the production of drug loaded particles with precisely engineered physical characteristics Under SBIR Phase I Lab to Marketplace funding we designed and optimized a multi nozzle unit consisting of individual nozzles capable of producing uniform poorly water soluble drug containing microparticles of defined size and release characteristics With this multi nozzle unit design we succeeded in our Phase I goal of establishing the feasibility of improving PPF production rate for encapsulation of poorly soluble drugs The objective of this SBIR Phase II proposal is to incorporate of these multi nozzle units into a cGMP ready electronically controlled and monitored PPF processing device that will be capable of producing homogenously distributed mm microparticles at a pilot scale production rate of kg hr and will be compatible with poorly water soluble drugs We will design assemble and fully test the mechanical subsystems of this PPF system Aim In parallel we will also design assemble and test a fully integrated electrical system with a graphical user interface GUI that will control the mechanical subsystems and regulate key process parameters including critical temperatures and pressures Aim Finally we will integrate the mechanical and electrical components and optimize the system to achieve target performance metrics and particle specifications Aim Development of such a system will demonstrate the feasibility of scaling the multi nozzle PPF system for full commercial scale production and derisk outside investment in the technology thereby enabling companies to partner in the co development of PPF enabled products This proposal lays the groundwork for a platform to produce aseptic but non sterile drug intermediates with release rates determined by the design of the microparticles themselves not the final dosage format thus they may be processed into a variety of oral delivery formats without altering the drug release characteristics This enables large degree of format flexibility in the development of pharmaceutical products minimizing development costs and improving patient compliance PUBLIC HEALTH RELEVANCE Poorly water soluble drug molecules are often rejected in the early stages of research and development even when they are projected to have high clinical efficacy because of the high cost and technical difficulties involved in the formulation and manufacture of effective drug delivery systems Orbis Biosciencesandapos novel Precision Particle Fabrication PPF technology has the potential to allow flexible cost effective scalable single step encapsulation of these poorly soluble drugs while also providing precise control over particle size shape composition and drug release profiles PPFandapos s level of control over a particleandapos s physical characteristics enables the design of more effective drug delivery systems with precisely controlled release better bioavailability improved palatability and greater formulation flexibility to address needs within the clinical space and the commercial market
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 491.33K | Year: 2013
Combat ration Intermediate Moisture (IM) products currently use low pH and water content (aw) to discourage bacterial growth. The long-term goal of this SBIR project is to maintain the microbial stability of IM ration components over a three-year shelf life while increasing the pH and aw values for an improved organoleptic profile by incorporation of First Generation Controlled Release Bacteriocin/Antimicrobial (FGCRB/A). The specific objective of this Phase II application is to develop microspheres for continuous, controlled-release of antimicrobials capable of maintaining the microbial stability of IM rations with improved organoleptic characteristics after exposure to all of the relevant food manufacturing processes. This approach will provide for a safe, high-quality IM ration platform that satisfies the Warfighterfs demand for variety and palatability while reducing the amount of chemical preservatives. Orbis is uniquely qualified to achieve this objective because of our microparticle fabrication expertise, patented particle fabrication technology, and partnership with shelf-stable food experts at RDI Foods. We will also develop a cost-effective, scalable manufacturing process for bisin, the first bacteriocin effective against both gram-positive and gram-negative pathogens and incorporate this ingredient into our Phase II FGCRB/A prototype.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 216.02K | Year: 2012
DESCRIPTION (provided by applicant): Pediatric drug development presents many unique challenges in the effective treatment of diseases in children, from adequate dosing information and pediatric-specific testing to palatable flavor profiles and effective delivery formats. A novel technology that masks bitter drug flavors while providing flexibility in dose design and format would enable formulation of existing adult pharmaceutical products into medications specially designed for pediatric patients. Our proposed strategy uses Precision Particle Fabrication (PPF) to develop pediatric drug-loaded microparticles that mask bitter flavors and allow for flexible dosing and formats. The central advantage of PPF technology lies in its precise control of particle size, shape, material, and release rates. Our long-term goal is to adapt this flexible, user-friendly, inexpensive technology to create a platform for microencapsulating unpalatable pediatric active pharmaceutical ingredients (API's). We hypothesize that theuniform, precisely engineered microparticles produced by PPF will create effectively taste- masked formulations for pediatric drugs while also allowing for the swift and controlled release of the active agents under digestive conditions. We further hypothesize that this robust microparticle strategy will allow for accurate, flexible dosing and adaptation to multiple drug delivery formats. Our research team will develop and characterize model bitter API-containing microparticles with precisely controlled physicochemical features that are designed to meet palatability standards (Aim 1). We will then optimize the release characteristics and taste-masking performance of these model microparticles (Aim 2). The result will be model drug-loaded microparticles thatmeet palatability standards based on particle size, homogeneity, and drug surface concentration and that can be tailored for desired release profiles under digestive conditions. After establishing the feasibility of precisely engineering these microparticles, Phase II will focus on the clinical evaluation of organoleptic properties of taste and mouth feel as well as demonstration of dosing accuracy, titration, and format flexibility. This PPF-based encapsulation strategy addresses issues of palatability, dosage accuracy, and format flexibility in pediatric drugs, while improving upon existing encapsulation techniques that are costly and time-consuming and produce poorly controlled, heterogeneous batches of microparticles. In adition, this PF technology is highly adaptable to multiple drugs and matrix/coating materials as well as large-scale production. The result will be an inexpensive, highly flexible pediatric platform for creating palatable, age-appropriate, and accurate dosage forms, leading to safer pediatric formulations and improved patient compliance. PUBLIC HEALTH RELEVANCE: Inadequate pediatric pharmaceutical formulations impair effective treatment of diseases in children due to poor compliance, ad hoc formulations, and dangerous medicationerrors. At the foundation of the problem are palatability, accurate dosing, and age-appropriate dosage format challenges. Development of a user-friendly, inexpensive development platform for pediatric reformulation of existing adult drug products to administer taste-masked active pharmaceutical ingredients (APIs) with controlled release rates is needed. Using model bitter APIs, this project aims to test the feasibility of Precision Particle Fabricatio technology to produce palatable, age-appropriate, and accurate doses as a means to safer pediatric medications and better compliance.
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2015
DESCRIPTION provided by applicant New treatment options are needed for inner ear disorders including Meniereandapos s disease sensorineural hearing loss autoimmune inner ear disease and tinnitus In the absence of FDA approved drugs physicians use improvised treatments including the administration of off label steroids which lack safety and efficacy data These ad hoc approaches often fail to achieve the desired outcomes a result potentially attributable to insufficient and variable drug exposure in the inner ear Orbis Biosciencesandapos s extended release inner ear drug delivery platform Unison has the potential to significantly improve treatment for a wide range of otic disorders by maintaining precise and therapeutic drug levels in the inner ear for more than thirty days after a single cost effective intratympanic injection The Unison platform is a composite of drug loaded microspheres produced using Orbisandapos patented Precision Particle Fabrication technology that allow for precise control of drug release and a novel Fast Film forming Agent FFA that severs as both a diluent for microsphere injection and a film that holds the microspheres to the Round Window Membrane RWM allowing the microspheres to continuously deliver their drug payload to the inner ear for over a month The first product to use the Unison platform is ORB an extended release betamethasone for the treatment of steroid responsive otic disorders Upon successful FDA approval ORB will replace the current clinical practice of multiple intratympanic injections of aqueous suspensions spaced over the course of several weeks a treatment that is painful inconvenient and often ineffective Under SBIR Phase I Orbis successfully developed a prototype of Unison and ORB Orbis used its patented Precision Particle Fabrication technology to successfully encapsulate and control the in vitro release of betamethasone a potent glucocorticoid steroid Concurrently Orbis developed a FFA capable of affixing microspheres in the RWM for over thirty days and demonstrated that this novel FFA was non toxic in mice The objective of this SBIR Phase II proposal is to demonstrate the safety and efficacy of ORB in preclinical models for both small and large animals and to hold a pre IND meeting with the FDA in preparation for an IND filing during Phase III of this SBIR program Orbis will first establish the in vitro in vivo correlation of ORB in guinea pigs along with shelf stability testing of the ORB components Aim Subsequently Orbis will characterize the safety pharmacology and toxicology of ORB in guinea pigs using an acute ototoxicity model Aim Finally Orbis will establish the dose response curve of ORB in a large animal sheep model Aim to characterize the dose requirements in an animal with inner ear fluid volume near the size of the human At the completion of this Phase II SBIR program Orbis will have established the safety and efficacy of ORB to achieve steady concentration of steroid in the inner ear for a minimum of thirty days in both small and large animal models thereby positioning the resultant formulation for IND enabling preclinical trials PUBLIC HEALTH RELEVANCE There are no FDA approved drugs for the treatment of inner ear diseases that afflict millions of Americans ever year In their place physicians often prescribe drugs off label that whether delivered orally or through local injection to the ear lack safety data and show widely variable clinical responses Orbis Biosciencesandapos s innovative inner ear drug delivery platform will enable cost effective local delivery and extended release of new and existing drugs thereby providing physicians and patients new safe and effective treatments for debilitating diseases of the inner ear
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 287.06K | Year: 2012
DESCRIPTION (provided by applicant): Current approaches to treat sudden sensorineural hearing loss (SSNHL) do not maintain inner ear drug concentrations within an appropriate therapeutic window for sufficient lengths of time to achieve therapeutic effect.A novel delivery system for long-term, controlled release of glucocorticoid steroids to the inner ear would constitute a dramatic improvement in SSNHL treatment options. Our proposed strategy uses Precision Particle Fabrication (PPF) to create betamethasone-loaded microspheres for transtympanic injection, round window membrane (RWM) localization, and sustained-release to the inner ear. The central advantage of our approach is that PPF technology allows for precise control of particle size, shape, material,and release rates. Our long-term goal is for transtympanic delivery of PPF-enabled betamethasone-loaded microspheres to be the standard-of-care for people who suffer from SSNHL. We hypothesize that microspheres can be retained on the RWM for two weeks andthat betamethasone release can be maintained within 25% of a therapeutic dose (~55 ng/day). We expect that this novel approach will enable sustained levels of therapeutic concentrations of betamethasone to the inner ear that will dramatically improve the safety and efficacy of SSNHL treatments over currently available options. Our research team will first develop and characterize the relationship between the microsphere size and betamethasone release profiles to establish the feasibility of achieving long-term, controlled release to the inner ear (Aim 1). We will then determine the optimal microsphere immobilization strategy to enable RWM localization for a minimum of 14 days with minimal toxicity (Aim 2). The result will be microspheres that sustain a precise betamethasone dose and adhere to the RWM for sufficient time. After establishing the feasibility of this approach, we will, in Phase II, demonstrate our ability to precisely control the pharmacokinetic profile of inner ear betamethasone concentrations in small (mouse) and large (sheep) animal models. This PPF- enabled drug-delivery strategy addresses issues of dosage accuracy and long-term release. In addition, PPF- based encapsulation is highly adaptable and can serve as a transtympanic delivery platform for multiple drug classes. This unique strategy has significant potential to become the standard-of-care for treatment of SSNHL. PUBLIC HEALTH RELEVANCE: Current approaches to treat sudden sensorineural hearing loss (SSNHL) do not maintain innerear drug concentrations within an appropriate therapeutic window for sufficient lengths of time to achieve therapeutic effect. A novel delivery system for long-term, controlled release of glucocorticoid steroids to the inner ear would constitute a dramatic improvement in SSNHL treatment options. Our proposed strategy uses Precision Particle Fabrication (PPF) to engineer glucocorticoid-loaded microspheres that are designed to remain localized to the round-window membrane of the inner ear and provide controlled and sustained release of the therapeutic throughout the treatment period.
Agency: Department of Agriculture | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.07K | Year: 2014
Vaccination is a particularly powerful weapon in the fight against wide-spread livestock disease. Commercially available vaccines, however, are often difficult and costly for livestock producers to use properly, leaving individual animals - and by extension the global food supply - at risk. More specifically, many vaccines on the market today require multiple injections spaced several weeks apart (i.e. primer dose; two (or more) week delay period; booster dose) to achieve a protective level of immunity in the host animal. These booster doses are often not administered for a variety of reasons, including: (1) the cost and logistical difficulty of rounding up livestock that graze over large areas of land and (2) the nature of the livestock supply chain (e.g. the animal receives the primer does, but is sold to a finishing lot before the booster dose is administered). Taken together, there is a critical need for new livestock vaccines that eliminate the necessity for booster injections.