Indomethacin, lacidipine, nifedipine and tolbutamide are poorly soluble in water may show dissolution-related low oral bioavailability. This study describes the formulation characterization of these drugs as glass solutions with amorphous polymers polyvinylpyrrolidone (PVP) polyvinylpyrrolidone-co-vinyl acetate by melt extrusion. The extrudates were compared physical mixtures drug polymer. X-ray powder diffraction, thermal analysis, infrared spectroscopy, scanning electron microscopy, HPLC,...

Injection using needle and syringe (N&S) is the most widely used method for vaccination, but requires trained healthcare workers. Fear of needles, risk needle-stick injury, need to reconstitute lyophilised vaccines, are also drawbacks. The Nanopatch (NP) a microarray skin patch comprised high-density array microprojections dry-coated with vaccine that being developed address these shortcomings. Here we report randomised, partly-blinded, placebo-controlled trial represents first use in humans...

Background The Vaxxas high-density microarray patch (HD-MAP) consists of a high density microprojections coated with vaccine for delivery into the skin. Microarray patches (MAPs) offer possibility improved thermostability as well potential to be safer, more acceptable, easier use, and cost-effective administration vaccines than injection by needle syringe (N&S). Here, we report phase I trial using HD-MAP deliver monovalent influenza that was best our knowledge first clinical evaluate safety,...

The aim of this study was to investigate the use small-scale fusion experiments and Gordon-Taylor (GT) equation predict whether melt extrusion a drug with an amorphous polymer produces stable dispersion increased dissolution. Indomethacin, lacidipine, nifedipine, piroxicam, tolbutamide were used as poorly soluble drugs. Drug/polyvinylpyrrolidone (PVP) blends prepared at 1:1 mass ratio. Small-scale performed in differential scanning calorimeter (DSC) stainless steel beakers. Extrusion...

Most vaccinations are performed by intramuscular injection with a needle and syringe. However, this method is not ideal due to limitations, such as the risk of needle-stick injury, requirement for trained personnel give injections need reconstitute lyophilized vaccines. Therefore, we tested an alternative delivery technology that overcomes problems The Nanopatch™ array 10,000 silicon micro-projections per cm2 can be dry-coated vaccine skin delivery. high number density means velocity...

Carbamazepine and dipyridamole are class II compounds (BCS) whose oral bioavailability is limited by poor solubility. The use of glass solutions to improve the this compound has been an area research for a number years. influence polymer parameters (Tg, hydrophilicity, solubility parameter, ability hydrogen bond) on solution properties investigated.Carbamazepine prepared with PVP/VA 64 37 spray drying melt extrusion. products then characterized XRPD, thermal, spectroscopic methods. Yield,...

To secure a polio-free world, the live attenuated oral poliovirus vaccine (OPV) will eventually need to be replaced with inactivated vaccines (IPV). However, current IPV delivery is less suitable for campaign use than OPV, and more expensive. We are progressing microarray patch platform, Nanopatch, as an easy-to-use device administer vaccines, including IPV. The Nanopatch contains ultra-high density array (10,000/cm2) of short (~230 μm) microprojections that delivers dry coated into skin....

Microarray patches (MAPs) have the potential to be a safer, more acceptable, easier-to-use, and cost-effective means for administration of vaccines than injection by needle syringe. Here, we report findings from randomized, partially double-blinded, placebo-controlled Phase I trial using Vaxxas high-density MAP (HD-MAP) deliver measles rubella (MR) vaccine. Healthy adults (N = 63, age 18–50 years) were randomly assigned 1:1:1:1 four groups: uncoated (placebo) HD-MAPs, low-dose MR HD-MAPs...

We have characterised the stable polymorphic forms of two drug molecules, indomethacin (1) and nifedipine (2) by 13C CPMAS NMR resonances been assigned. The signal for C-Cl carbon has studied as a function applied magnetic field, observed bandshapes simulated. Variable-temperature 1H relaxation measurements static samples revealed T1rho minimum at 17.8 degrees C. associated activation energy is 38 kJ mol(-1). relevant motion probably an internal rotation it suggested that this involves...

The high-density microneedle array patch (HD-MAP) is a novel vaccine delivery system with potential for self-administered vaccination. In this study, Vaxxas HD-MAPs were applied by both trained user and application sites compared to determine the response of skin level engagement HD-MAP human skin. Twenty healthy participants enrolled, including erythema was observed at all no difference found between or applications. majority (70%) preferred deltoid upper arm site applying HD-MAPs....

The human papillomavirus (HPV) 9-valent, recombinant vaccine (Gardasil™9) helps protect young adults (males and females) against anogenital cancers genital warts caused by certain HPV genotypes (ref. Gardasil™9 insert). This is administered intramuscularly (IM). aim of this study was to determine preclinically whether intradermal (ID) vaccination with an unadjuvanted 9-valent using a first-generation ID delivery device, the Nanopatch™, could enhance immunogenicity compared traditional route...

Abstract The development of microarray patches for vaccine application has the potential to revolutionise delivery. Microarray (MAP) reduce risks needle stick injury, do not require reconstitution and have enhance immune responses using a fractional dose. To date, majority research focused on delivery with little characterisation local skin response recovery. Here we study in detail immediate recovery post high density MAP 12 individuals receiving 3 MAPs randomly assigned forearm upper arm....

The worldwide switch to inactivated polio vaccines (IPVs) is a key component of the overall strategy achieve and maintain global eradication. To this end, new IPV vaccine delivery systems may enhance patient convenience compliance. In work, we examine Nanopatch™ (a solid, polymer microprojection array) which offers potential advantages over standard needle/syringe administration including intradermal reduced antigen doses. Using trivalent (tIPV) purpose-built evaporative dry-down system,...

Background High-density microarray patch (HD-MAP) vaccines may increase vaccine acceptance and use. We aimed to ascertain whether professional immunizers (PIs) other healthcare workers (HCWs) in Australia, a High-Income Country (HIC), found the HD-MAP applicator usable acceptable for delivery.Methods This feasibility study recruited PIs HCWs administer/receive simulated administration, including via self-administration. assessed usability against essential desirable criteria. Participants...

We evaluated vaccination against Streptococcus pyogenes with the candidate vaccine, J8-DT, delivered by a high-density microarray patch (HD-MAP). showed that J8-DT eluted from coated HD-MAP (J8-DT/HD-MAP), induced similar total IgG responses to generated adjuvanted Alum (J8-DT/Alum). effect of dose reduction and number vaccinations on antibody response profile vaccinated mice. A in (from three two) J8-DT/HD-MAP comparable intramuscular J8-DT/Alum. Vaccine-induced protection an S. skin...

Measles (Me) and rubella (Ru) viral diseases are targeted for elimination by ensuring a high level of vaccination coverage worldwide. Less costly, more convenient MeRu vaccine delivery systems should improve global coverage, especially in low - middle income countries (LMICs). In this work, we examine formulating live, attenuated Me Ru combination with Nanopatch™, solid polymer micro-projection array intradermal delivery. First, throughput, qPCR-based infectivity genome assays were...

Continued advances in microarray patch (MAP) technology are starting to make needle-free delivery of a broad range vaccines an achievable goal. The drivers and potential benefits MAP platform for pandemic response routine vaccination clear include dose-sparing, cold-chain elimination, increased safety, self-administration. is regarded as priority innovation overcome barriers, ensure equitable access, improve the effectiveness vaccines. Vaxxas, global leader this technology, has built strong...

Microarray patches (MAPs) have the potential to be a safer, more acceptable, easier use, and cost-effective means for administration of vaccines than injection by needle syringe. Here, we report findings from randomized, partially double-blind, placebo-controlled Phase I trial using Vaxxas high-density MAP (HD-MAP) deliver measles rubella (MR) vaccine. Healthy adults (N = 63, age 18–50 years) were randomly assigned 1:1:1:1 four groups: uncoated (placebo) HD-MAPs, low-dose MR HD-MAPs (~3,100...