Orally Disintegrating Film of High-Dose BCS II Drug by Hot Melt Extrusion through Design of Experiment

Phadke, Apoorva; Amin, Purnima D.

doi:10.1007/s12247-022-09631-3

Cited by 2 publications

(1 citation statement)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The film formulations demonstrated fast disintegration (6 to 11 s) and demonstrated over 95% dissolution within 5 min [ 27 ]. In a recent investigation, HME was employed to achieve the continuous production of ODFs containing a substantial dosage of nimesulide, classified as a BCS II compound [ 114 ]. A mechanically robust film was successfully formulated, exhibiting an exceptional drug-loading percentage of up to 21.73% w / w and showcasing an optimal drug-release profile, further highlighting its effectiveness.…”

Section: Manufacturing Methodsmentioning

confidence: 99%

Orodispersible Films: Current Innovations and Emerging Trends

Jacob,

Boddu,

Bhandare

et al. 2023

Pharmaceutics

View full text Add to dashboard Cite

Orodispersible films (ODFs) are thin, mechanically strong, and flexible polymeric films that are designed to dissolve or disintegrate rapidly in the oral cavity for local and/or systemic drug delivery. This review examines various aspects of ODFs and their potential as a drug delivery system. Recent advancements, including the detailed exploration of formulation components, such as polymers and plasticizers, are briefed. The review highlights the versatility of preparation methods, particularly the solvent-casting production process, and novel 3D printing techniques that bring inherent flexibility. Three-dimensional printing technology not only diversifies active compounds but also enables a multilayer approach, effectively segregating incompatible drugs. The integration of nanoparticles into ODF formulations marks a significant breakthrough, thus enhancing the efficiency of oral drug delivery and broadening the scope of the drugs amenable to this route. This review also sheds light on the diverse in vitro evaluation methods utilized to characterize ODFs, ongoing clinical trials, approved marketed products, and recent patents, providing a comprehensive outlook of the evolving landscape of orodispersible drug delivery. Current patient-centric approaches involve developing ODFs with patient-friendly attributes, such as improved taste masking, ease of administration, and enhanced patient compliance, along with the personalization of ODF formulations to meet individual patient needs. Investigating novel functional excipients with the potential to enhance the permeation of high-molecular-weight polar drugs, fragile proteins, and oligonucleotides is crucial for rapid progress in the advancing domain of orodispersible drug delivery.

show abstract

Section: Manufacturing Methodsmentioning

confidence: 99%

Orodispersible Films: Current Innovations and Emerging Trends

Jacob,

Boddu,

Bhandare

et al. 2023

Pharmaceutics

View full text Add to dashboard Cite

show abstract

Orodispersible Film Fabrication by Hot Melt Extrusion for Dental Pain Amelioration by Quality by Design Approach

Phadke¹,

Amin²

2023

IND. DRU.

View full text Add to dashboard Cite

Surgical dental procedures cause pain and inflammation leading to temporary restriction of the movement of the oral cavity. Consumption of analgesic medications in the form of tablets or dispersible tablets causes compliance issues due to the compromised movability of the mandibular joint. An Orally Disintegrating Film (ODF), due to its pliability and compact size, can be a patient compliant tool for management of postoperative dental pain over parenterally administered opioids, conventional as well as orodispersible tablets of steroids or NSAIDS. Due to the inadequacies involved in solvent-casting, an unmet need exists for a continuous, eco-friendly and patient compliant process of manufacturing. The present research work addresses the unmet need of a patient compliant delivery system containing ketorolac tromethamine by Hot Melt Extrusion. The ODF optimized by Quality by Design was found to be stable with excellent mechanical properties and provided superior release profile as compared to the equivalent marketed formulation.

show abstract

Orally Disintegrating Film of High-Dose BCS II Drug by Hot Melt Extrusion through Design of Experiment

Cited by 2 publications

References 25 publications

Orodispersible Films: Current Innovations and Emerging Trends

Orodispersible Films: Current Innovations and Emerging Trends

Orodispersible Film Fabrication by Hot Melt Extrusion for Dental Pain Amelioration by Quality by Design Approach

Contact Info

Product

Resources

About