Product transfer from lab-scale to pilot-scale of quetiapine fumarate orodispersible films using quality by design approach

Bülbül, Ece Özcan; Mesut, Burcu; Cevher, Erdal; Öztaş, Ezgi; Özsoy, Yıldız

doi:10.1016/j.jddst.2019.101358

Cited by 19 publications

(7 citation statements)

References 35 publications

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“…The solvent casting method is the most common technique applied for the preparation of single or multilayer films on a lab-scale as well as industrial continuous production [ 18 , 24 ]. The API is dispersed or dissolved in a polymer solution containing plasticizer or other auxiliary substances and then cast with the defined thickness on an intermediate liner using a film applicator [ 16 , 18 , 20 , 21 , 25 ] or a coating machine [ 18 ]. After drying at room or high temperature, the films are rolled up in jumbo rolls, divided into smaller daughter rolls, and finally cut into individual drug units and packed in sachets or other single-dose containers [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

The Impact of the Preparation Method on the Properties of Orodispersible Films with Aripiprazole: Electrospinning vs. Casting and 3D Printing Methods

et al. 2021

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Orodispersible films (ODFs) address the needs of pediatric and geriatric patients and people with swallowing difficulties due to fast disintegration in the mouth. Typically, they are obtained using the solvent casting method, but other techniques such as 3D printing and electrospinning have already been investigated. The decision on the manufacturing method is of crucial importance because it affects film properties. This study aimed to compare electrospun ODFs containing aripiprazole and polyvinyl alcohol with films prepared using casting and 3D printing methods. Characterization of films included DSC and XRD analysis, microscopic analysis, the assessment of mechanical parameters, disintegration, and dissolution tests. Simplified stability studies were performed after one month of storage. All prepared films met acceptance criteria for mechanical properties. Electrospun ODFs disintegrated in 1.0 s, which was much less than in the case of other films. Stability studies have shown the sensitivity of electrospun films to the storage condition resulting in partial recrystallization of ARP. These changes negatively affected the dissolution rate, but mechanical properties and disintegration time remained at a desirable level. The results demonstrated that electrospun fibers are promising solutions that can be used in the future for the treatment of patients with swallowing problems.

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Section: Introductionmentioning

confidence: 99%

The Impact of the Preparation Method on the Properties of Orodispersible Films with Aripiprazole: Electrospinning vs. Casting and 3D Printing Methods

et al. 2021

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“…Quetiapine fumarate ODF production, at a pilot scale, has been executed through the solvent casting method, following the principles of quality by design [ 101 ]. The optimized films were prepared by employing HPMC E5 as the film former and propylene glycol as the plasticizer at a temperature range of 65–70 °C.…”

Section: Manufacturing Methodsmentioning

confidence: 99%

“…Addressing these challenges requires meticulous planning, optimization of processes, and a commitment to maintaining high-quality standards throughout the scaled-up production of ODFs. Quetiapine fumarate ODF production, at a pilot scale, has been executed through the solvent casting method, following the principles of quality by design [101]. The optimized films were prepared by employing HPMC E5 as the film former and propylene glycol as the plasticizer at a temperature range of 65-70 • C.…”

Section: Solvent Castingmentioning

confidence: 99%

Orodispersible Films: Current Innovations and Emerging Trends

Jacob,

Boddu,

Bhandare

et al. 2023

Pharmaceutics

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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.

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“…The assay was carried out at 232 nm and the dissolution medium was used as blind. The experiment was repeated three times [44].…”

Section: In Vitro Drug Release Studiesmentioning

confidence: 99%

Preparation and detailed characterization of fusidic acid loaded in situ gel formulations for ophthalmic application

Rençber¹,

Bulbul²,

Okur³

et al. 2021

jrp

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Product transfer from lab-scale to pilot-scale of quetiapine fumarate orodispersible films using quality by design approach

Cited by 19 publications

References 35 publications

The Impact of the Preparation Method on the Properties of Orodispersible Films with Aripiprazole: Electrospinning vs. Casting and 3D Printing Methods

The Impact of the Preparation Method on the Properties of Orodispersible Films with Aripiprazole: Electrospinning vs. Casting and 3D Printing Methods

Orodispersible Films: Current Innovations and Emerging Trends

Preparation and detailed characterization of fusidic acid loaded in situ gel formulations for ophthalmic application

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