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Formulations for small intestinal delivery

A technology of ileum and enteric coating, which is applied in the direction of medical preparations containing active ingredients, drug delivery, pill delivery, etc., and can solve the problems of expensive aseptic filling and handling of syringe needles, etc.

Active Publication Date: 2016-12-21
VAXART INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Cell culture or plant-derived hemagglutinin (HA) can reduce the burden of egg harvesting and processing, but these methods still require expensive sterile filling and handling to produce individual syringe needles that need to be treated as biohazards. disposal

Method used

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  • Formulations for small intestinal delivery
  • Formulations for small intestinal delivery
  • Formulations for small intestinal delivery

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0112] To determine which region of the small intestine is most effective in inducing an immune response to an antigen, tests were performed in humans. Radio-controlled capsules were administered to healthy normal volunteers, where the vaccine was released in either the front part of the small intestine (jejunum) or the back part of the small intestine (ileum). The delivery of small molecule drugs using radio-controlled capsules has been described, but not the delivery of vaccines (Digenis et al. (1991) Crit. Rev. Ther. Drug Carrier Syst. 7:309).

[0113] The vaccine consists of a recombinant adenovirus (rAd-HA-dsRNA) expressing the influenza antigen HA from A / CA / 04 / 2009 (see, eg, US2012 / 0244185). On Day 0, subjects were given a total of 10 11 infection unit (IU). The number of circulating proplasma B cells in peripheral blood was measured by antibody secreting cell (ASC) assay at day 0 and day 7 after vaccine administration. Results Only the number of ASCs recognizing the ...

Embodiment 2

[0118] Tablets were hand-made using microcrystalline cellulose (PH-101, FMC) and starch (Starch 1500, Colorcon), which incorporated 10% barium sulfate as the radiopaque material, fumed silica as a glidant, and stearin Magnesium Oxide as a tablet lubricant. Tablets with a diameter of 7.14 mm and a weight of 150 mg were coated in a pan coater using the 10% coating solids weight gain as a guide for whether to add an enteric coating L-100; Coating Solid contains 4 parts polymer with 1 part triethyl citrate and 1 part talc. As an initial test of enteric coating performance, four cynomolgus monkeys were given the tablets using an oral gastric tube. Oral gastric tubes are solid and rigid, but hollow along the middle for dripping fluids. It has a flexible silicone tube at the leading end of the rigid tube that holds a small tablet in place. The tube and bolus device was passed down the esophagus of the control monkey until the leading end passed the cardiac sphincter and entered...

Embodiment 3

[0122] A Phase 1 , serial enrollment clinical study was completed in which the safety and immunogenicity of a recombinant Ad serotype 5 (rAd5) based oral vaccine against H1 seasonal influenza was evaluated in a randomized and placebo-controlled cohort. The rAd5 vector (rAd-HA-dsRNA with HA from A / C A / 04 / 2009) is described in Example 1. The study had an approximately 3-month validity period and was conducted in accordance with applicable good clinical practice guidelines, US code of federal regulations and International Harmonized Conference specifications. Informed consent was obtained from all subjects after discussion of risks. Obtain approval from the IRB prior to administering the drug to the subject.

[0123] at Lonza Biologicals (Houston, TX) Good manufacturing practice (GMP) grade rAd-HA-dsRNA was produced in pouches (GE Healthcare, Waukesha, WI). Purification was performed by ion exchange chromatography followed by buffer exchange. The purified carrier was mixed w...

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Abstract

Provided herein are compositions and methods for generating an immunogenic response in humans. Such compositions include an immunogenic biological agent encompassed by (ii) an agent that directs delivery of the immunogenic biological agent to the ileum of the human, wherein agent (ii) is an enteric coating (e.g., Eudragit ) that has a threshold pH 5.8-6.8. Further provided are methods for designing such compositions, e.g., for vaccines.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application No. 61 / 942,386, filed February 20, 2014, the disclosure of which is incorporated herein in its entirety. Background of the invention [0003] Vaccines are an important means of preventing and / or treating a number of diseases and conditions (eg, viral infections, bacterial infections, and cancer). Often, serial vaccinations are administered using injections, which reduces participation due to inconvenient access to vaccination sites and aversion to injections. Furthermore, the injection of the vaccine requires the use of a sterile kit, such as a syringe and needle, and requires the administration of a skilled professional. [0004] For influenza vaccines, large-scale campaigns are conducted each year to collect enough fertilized eggs to harvest and process enough virus to meet market demand. Cell culture or plant-derived hemagglutinin (HA) can reduce the bur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/00
CPCA61K2039/6093C12N2760/16134A61K9/2846A61P37/04A61K39/00A61K9/0053A61K9/2813A61K9/282A61K2039/5256A61K2039/542C12N2760/16171A61K39/145A61K2039/575C12N2710/10343A61K2039/572C12N7/00
Inventor 肖恩·塔克乔治·特拉格
Owner VAXART INC
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