Design and Evaluation of Ophthalmic Pharmaceutical Products

Jani, Rajni; Lang, John C.; Rodeheaver, D.; Missel, Paul J.; Roehrs, Robert; Chowhan, Masood

doi:10.1201/9780824744694.ch13

Cited by 3 publications

(2 citation statements)

References 23 publications

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“…Additionally, the buffer capacity of such formulations is of equal importance for proper preservation. Although, the buffering action of the tears is capable of neutralizing the effect of topically applied biopharmaceutical formulations[71], intraocular hyperosmotic solutions have been reported to elicit transient desiccation of the anterior chamber tissues while hypotonic solutions may cause edema leading to corneal clouding[72]. For this reason, pH of such formulations are compromised and maintained by buffers to achieve maximum activity and maintain stability[73].…”

Section: Proteins and Peptides: Challenges In Ocular Deliverymentioning

confidence: 99%

Ocular delivery of proteins and peptides: Challenges and novel formulation approaches

Mandal

Pal

Agrahari

et al. 2018

Advanced Drug Delivery Reviews

169

122

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The impact of proteins and peptides on the treatment of various conditions including ocular diseases over the past few decades has been advanced by substantial breakthroughs in structural biochemistry, genetic engineering, formulation and delivery approaches. Formulation and delivery of proteins and peptides, such as monoclonal antibodies, aptamers, recombinant proteins and peptides to ocular tissues poses significant challenges owing to their large size, poor permeation and susceptibility to degradation. A wide range of advanced drug delivery systems including polymeric controlled release systems, cell-based delivery and nanowafers are being exploited to overcome the challenges of frequent administration to ocular tissues. The next generation systems integrated with new delivery technologies are anticipated to generate improved efficacy and safety through the expansion of the therapeutic target space. This review will highlight recent advances in formulation and delivery strategies of protein and peptide based biopharmaceuticals. We will also describe the current state of proteins and peptides based ocular therapy and future therapeutic opportunities.

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Section: Proteins and Peptides: Challenges In Ocular Deliverymentioning

confidence: 99%

Ocular delivery of proteins and peptides: Challenges and novel formulation approaches

Mandal

Pal

Agrahari

et al. 2018

Advanced Drug Delivery Reviews

169

122

View full text Add to dashboard Cite

show abstract

“…A weak acidic buffer is optimal for the storage of antibodies, i.e., adalimumab (pH 5.2), ranibizumab (pH 5.5), and bevacizumab (pH 6.2), below their isoelectric points (~8.3–8.8) for ocular treatments [ 93 , 94 ]. Though buffers play a crucial role in providing stability and preservation of macromolecules, their use must be carefully considered to avoid associated complications such as immunogenicity and local toxicity [ 95 ]. Buffers used also must be within the osmolarity range (280–300 mOsm/kg) to be compatible with ocular tissues as they also impair tonicity.…”

Section: Ocular Barriers and Approaches To Ocular Administrationmentioning

confidence: 99%

Ocular Delivery of Therapeutic Proteins: A Review

2023

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Therapeutic proteins, including monoclonal antibodies, single chain variable fragment (ScFv), crystallizable fragment (Fc), and fragment antigen binding (Fab), have accounted for one-third of all drugs on the world market. In particular, these medicines have been widely used in ocular therapies in the treatment of various diseases, such as age-related macular degeneration, corneal neovascularization, diabetic retinopathy, and retinal vein occlusion. However, the formulation of these biomacromolecules is challenging due to their high molecular weight, complex structure, instability, short half-life, enzymatic degradation, and immunogenicity, which leads to the failure of therapies. Various efforts have been made to overcome the ocular barriers, providing effective delivery of therapeutic proteins, such as altering the protein structure or including it in new delivery systems. These strategies are not only cost-effective and beneficial to patients but have also been shown to allow for fewer drug side effects. In this review, we discuss several factors that affect the design of formulations and the delivery of therapeutic proteins to ocular tissues, such as the use of injectable micro/nanocarriers, hydrogels, implants, iontophoresis, cell-based therapy, and combination techniques. In addition, other approaches are briefly discussed, related to the structural modification of these proteins, improving their bioavailability in the posterior segments of the eye without affecting their stability. Future research should be conducted toward the development of more effective, stable, noninvasive, and cost-effective formulations for the ocular delivery of therapeutic proteins. In addition, more insights into preclinical to clinical translation are needed.

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Combinatorial Drug Therapy for Controlling Pseudomonas aeruginosa and Its Association With Chronic Condition of Diabetic Foot Ulcer

Srivastava

Karthikeyan

2019

The International Journal of Lower Extremity Wounds

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Diabetic foot ulcer (DFU) is a major complication of diabetes mellitus, major observations of DFU cases have reported on amputation of foot region, and microbial bioburden during DFU is a major cause that affects healing of the wound regions. Pathogenic microbes are routinely isolated from these wound regions, especially Staphylococcus, Pseudomonas, Klebsiella, and Escherichia coli have been reported, whereas higher prevalence of Pseudomonas species during chronic condition in the deeper part of the wound, when left untreated, leads to gangrene. Multiple drug-resistant Pseudomonas strains are a new threat because of their biofilm-forming ability, making it more potent and incurable. Acyl homoserine lactones (AHL) are a group of signaling molecules that can regulate biofilm growth, and Las and Rhl operon generally work in tandem to initiate biofilm formation by Pseudomonas species. These signaling molecules also initiate virulence factors that correlates upregulation of inflammatory responses, and AHL can be a therapeutic target in order to prevent the efficacy of multiple drug-resistant strains that form biofilm and also can be an alternative solution against control of multiple drug-resistant strains.

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Design and Evaluation of Ophthalmic Pharmaceutical Products

Cited by 3 publications

References 23 publications

Ocular delivery of proteins and peptides: Challenges and novel formulation approaches

Ocular delivery of proteins and peptides: Challenges and novel formulation approaches

Ocular Delivery of Therapeutic Proteins: A Review

Combinatorial Drug Therapy for Controlling Pseudomonas aeruginosa and Its Association With Chronic Condition of Diabetic Foot Ulcer

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