Physicochemical and Preclinical Evaluation of a Novel Buccal Measles Vaccine

Gala, Rikhav P.; Popescu, Carmen; Knipp, Gregory T.; McCain, Robyn; Ubale, Ruhi V.; Addo, Richard T.; Bhowmik, Tuhin; Kulczar, Christopher D.; D’Souza, Martin J.

doi:10.1208/s12249-016-0566-3

Cited by 50 publications

(39 citation statements)

References 46 publications

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“…Tian et al developed an ODF based on a blend of trehalose and pullulan for protein delivery [10]. Morales et al developed insulin-coated nanoparticles for insulin permeation through the mucosa [78], an ODF containing a microparticulate measles vaccine formulation for buccal delivery has been developed by Gala et al [82], and an ODF with probiotics has been developed by Heinemann et al [83]. Due to the very low log P value of biopharmaceuticals, passive diffusion is limited.…”

Section: Biopharmaceuticalsmentioning

confidence: 99%

Oromucosal films: from patient centricity to production by printing techniques

Tian

Orlu

Woerdenbag

et al. 2019

Expert Opinion on Drug Delivery

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Introduction: Oromucosal films, comprising mucoadhesive buccal films (MBFs) and orodispersible films (ODFs), are considered patient-centric dosage forms. Target groups are patients with special needs. Various active pharmaceutical ingredients have been shown to be suitable for oromucosal film production. A shift is seen in the production techniques, from conventional solvent casting to printing techniques. Areas covered: In this review, the patient acceptability of oromucosal films is discussed. An overview is given of the small molecule drugs, biopharmaceuticals and herbal extracts that have been incorporated so far. Finally, the current state of 2D and 3D printing techniques for production purposes is discussed. Expert opinion: The patient-centric features are important for the further development and acceptance of this oral solid dosage form. Oromucosal films perfectly fit in the current attention for personalized medicine. Both MBFs and ODFs are intended for either a local or a systemic effect. For buccal absorption, sufficient mucoadhesion is one of the most important criteria an oromucosal film must comply with. For the preparation, the solvent casting technique is still predominately used. Some limitations of this production method can be tackled by printing techniques. However, these novel techniques introduce new requirements, yet to be set, for oromucosal film preparation.

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Section: Biopharmaceuticalsmentioning

confidence: 99%

Oromucosal films: from patient centricity to production by printing techniques

Tian

Orlu

Woerdenbag

et al. 2019

Expert Opinion on Drug Delivery

View full text Add to dashboard Cite

show abstract

“…It is interesting to note that the permeability of buccal mucosa is approximately 4-4,000 times greater than that of the skin, but less than that of the intestine [69]. An ideal fast dissolving delivery system should have the following properties: high stability, transportability, ease of handling and administration, no special packaging material or processing requirements, no water necessary for application, and a pleasant taste [69]. Although current vaccines are proven to be highly effective, they exhibit several drawbacks that need to be addressed.…”

Section: Quickly Soluble Film Based Buccal Vaccine Delivery Systemmentioning

confidence: 99%

Overview and Future Potential of Fast Dissolving Buccal Films as Drug Delivery System for Vaccines

et al. 2019

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Vaccination is considered one of the most successful public health interventions of the modern era. Vaccines are categorized based on the antigen used, delivery system and the route of administration. Traditional vaccines are produced from the dead, attenuated or inactivated pathogens that cause disease. However, newly developed vaccines are DNA based, liposome based, and virus like particle (VLP) based which are more effective and specific to some malignant diseases. The delivery system of vaccines has been advanced along with time as well. New delivery systems such as nanoparticles, liposomes, or cells (for DNA) has been proven to develop a more efficient vaccine. Most vaccines are administered via intramuscular (IM), subcutaneous (SQ) or oral (PO) route. However, these routes of administration have limitations and side effects. An alternative route could be oral cavity administration such as buccal or sublingual administration using film dosage form as delivery vehicle. In this article, we thoroughly reviewed the possibility of developing a quickly soluble film-based delivery system for vaccine administration. We reviewed the different types of new vaccines and vaccine formulations such as VLP based, liposome, bilosome, particulate, and summarized their suitability for use in a film dosage form. Quickly soluble film dosage form is the most optimized form of buccal administration. A film dosage form applied in the buccal cavity has several advantages: they can avoid first pass effect, they are easy to administer and prepare, and they are more cost effective. Since there is no first pass effect, only a small quantity of the vaccine is needed. Vaccines in their original form or in a nano or microparticulate form can be used in a film. The film can also be developed in multilayers to protect the vaccine from degradation by saliva or swallowing. Films are easy to prepare, administer, and can be used for systemic and local action. In addition, most of the current vaccines use mostly the parenteral route of administration, which has some major drawbacks such as poor induction of mucosal immunity, less patient compliant, less potent, high cost and cumbersome production process. Sublingual and buccal vaccine delivery can be good alternatives as they are easier to prepare and safer than parenteral administration routes. The buccal and sublingual administration have the advantage to produce both systemic and mucosal immunity.

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“…Blood samples were collected prior to prime dose and every 2 weeks after dosing. The antibody levels in the blood were measured using specific indirect ELISA (42).…”

Section: Immunogenicity Of Whole-cell N Gonorrhoeae Nanovaccine Admimentioning

confidence: 99%

Novel Whole-Cell Inactivated <em>Neisseria Gonorrhoeae</em> Microparticle Vaccine Formulation in Microneedles for Transdermal Immunization

Gala¹,

Zaman²,

D’Souza³

et al. 2018

Preprint

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Neisseria gonorrhoeae is a strict human pathogen responsible for more than 100 million new sexually transmitted infections worldwide each year. Due to the global emergence of antibiotic resistance, the CDC recently listed N. gonorrhoeae as an urgent threat to public health. No vaccine is available in spite of the huge disease burden and the possibility of untreatable gonorrhea. The aim of this study is to investigate the immunogenicity of a novel whole-cell based inactivated gonococcal microparticle vaccine formulation loaded in dissolvable microneedles for transdermal administration. The nanotechnology-based vaccine formulation consists of inactivated whole-cell gonococci strain CDC-F62, spray dried and encapsulated into biodegradable cross-linked albumin matrix with sustained slow antigen release. The dry vaccine nanoparticles were then loaded in a dissolvable microneedle skin patch for transdermal delivery. The efficacy of the whole-cell microparticles vaccine formulation loaded in microneedles was assessed in vitro using dendritic ,cells and macrophages as well as in vivo mouse model. Antibody titers were measured using an ELISA and antigen-specific T lymphocytes were assessed in spleens and lymph nodes. Here we report that whole-cell based gonococcal microparticle vaccine loaded in dissolvable microneedles for transdermal administration induced significant increase in antigen-specific IgG antibody titers and antigen-specific CD4 and CD8 T lymphocytes in mice compared to gonococcal antigens in solution or empty microneedles. Significant increase in antigen-specific IgG antibody levels was observed at end of week 2 in groups that received the vaccine compared to the group receiving empty nanoparticles. The advantages of using formalin-fixed whole-cell gonococci that all immunogenic epitopes are covered and preserved from degradation. The spherical shaped micro and nanoparticles are biological mimics of gonococci, therefore present to the immune system as invaders but without the ability to suppress adaptive immunity. In conclusion, the transdermal delivery of microparticles vaccine via a microneedle patch was shown to be an effective system for vaccine delivery. The novel gonorrhea nanovaccine is cheap to produce in a stable dry powder and can be delivered in microneedle skin patch obviating the need for needle use or the cold chain.

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Physicochemical and Preclinical Evaluation of a Novel Buccal Measles Vaccine

Cited by 50 publications

References 46 publications

Oromucosal films: from patient centricity to production by printing techniques

Oromucosal films: from patient centricity to production by printing techniques

Overview and Future Potential of Fast Dissolving Buccal Films as Drug Delivery System for Vaccines

Novel Whole-Cell Inactivated <em>Neisseria Gonorrhoeae</em> Microparticle Vaccine Formulation in Microneedles for Transdermal Immunization

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