Development, optimization and in-vivo evaluation of cyanocobalamin loaded orodispersible films using hot-melt extrusion technology: A quality by design (QbD) approach

Suryawanshi, Dilipkumar; Wavhule, Pradipkumar; Shinde, Umesh; Kamble, Mamta; Amin, Purnima D.

doi:10.1016/j.jddst.2021.102559

Cited by 19 publications

(8 citation statements)

References 37 publications

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“…HME techniques, on the other hand, include benefits such as ease of shape, reduced operating units, low wastage, scalability, appropriateness for pharmaceuticals that are sensitive to moisture, and effectiveness of solubility improvement for APIs that are poorly soluble. HME techniques, however, are expensive and require specialized tools [28].…”

Section: Hot Melt Extrusionmentioning

confidence: 99%

A review on orodispersible drug delivery system

Iqbal,

Hanan,

Maqbool

et al. 2023

JCP

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The future of drug delivery holds great promise for orally dispersible dose formulations, which make application simple since no water requirement as compared to conventional solid dosage forms which requires significant volumes of fluids for administration. The objective for development of ODF provides a substitute for pills, syrups, and tablets in treating vomiting as well as nausea, particularly in children. On the basis of transdermal patch delivery system, a novel oral films drug delivery has been introduced. Fast dissolving films disintegrates quickly when come in contact with salivary secretion in the oral mucosa and released the drug fast approximately within 3 mins. ODFs are of different types, like sustained or controlled release, oral patches and fast dissolving films. They can be manufactured using a variety of method including solvent and semi solid casting, hot melt and solid dispersion extrusion, spray drying and rolling. Among them solvent casting method is the most employed method. ODFs comprises of active ingredient, polymer, plasticizer and additives like surfactants, sweetening and coloring agents. ODFs preparation requires hydrophilic polymer which provides quick dissolution in the oral cavity. Hydrophilic polymer act as base for ODFs formulation as they impart mouth feel and mechanical properties of the ODFs also dependent of polymer type. Oral thin-film provide fast drug dissolution precise dosage in a portable, safe, and handy manner that doesn't required water or any special equipment. This review article comprises of different methods for ODFs preparations, ODFs ingredients, ODFs benefits and drawbacks and their packaging.

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Section: Hot Melt Extrusionmentioning

confidence: 99%

A review on orodispersible drug delivery system

Iqbal,

Hanan,

Maqbool

et al. 2023

JCP

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“…Te APIs can be entrapped in an amorphous form that enhances their solubility and stability [5][6][7]. ODTFs can be manufactured by solvent casting and hot-melt extrusion technique [8,9]. Te texture, the taste in the mouth, and the size afect the acceptability of ODTFs.…”

Section: Introductionmentioning

confidence: 99%

Cellulose- and Saccharide-Based Orally Dispersible Thin Films Transform the Solid States and Dissolution Characteristics of Poorly Soluble Curcumin

Yusuf,

Savitri,

Al-Khalifi

et al. 2024

Advances in Pharmacological and Pharmaceutical Sciences

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This study aimed at developing and optimizing the orally dispersible thin film (ODTF) containing a plant-derived drug—curcumin (CUR). CUR belongs to a biopharmaceutical classification system (BCS) class IV compound that requires improving its water solubility and tissue permeability preceding formulation. An ODTF was applied to produce a solid dispersion matrix for CUR to resolve such solubility and permeability problems. The film-forming polymers used in the study were cellulose-based (hydroxypropyl methylcellulose/HPMC and carboxymethylcellulose/CMC) and saccharide-based maltodextrin (MDX). Poloxamer (POL) was also employed as surfactant and solubilizer. The solvent casting technique was applied to produce the films. The ethanolic solution of CUR was mixed with an aqueous solution of POLs and then incorporated into different film-forming polymers prior to casting. The processing of the CUR with POL solution was intended to aid in the even dispersion of the drug in the polymeric matrices and enhance the wettability of the films. The physical state and properties of the films were characterized in terms of their morphology, crystallinity of the drug, and phase miscibility of the mixtures. The dissolution profile of the films was also evaluated in terms of dissolution rate and dissolution efficiency. The obtained ODTF products were smooth and flat-surfaced. Physical characterization also indicated that the CUR was homogeneously dispersed in the ODTFs and no longer existed as crystalline material as revealed by X-ray diffraction (XRD). The CUR was also not phase-separated from the films as disclosed by differential scanning calorimetry (DSC). Such dispersion was achieved through the solubilizing effect of POLs and compact polymeric film matrices that prevented the CUR from recrystallization. Furthermore, the ODTFs also improved the dissolution of CUR by 3.2-fold higher than the raw CUR. Overall, cellulose-based films had favorable physical properties compared with saccharide-based films.

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“…The Box–Behnken design (BBD) is a statistical optimization design that is commonly used to investigate the impact of formulation and process variables on product quality attributes. BBD is a cost-effective and time-saving statistical design because it involves fewer experimental trials than other statistical designs [ 18 , 19 ].…”

Section: Introductionmentioning

confidence: 99%

Continuous Manufacturing of Solvent-Free Cyclodextrin Inclusion Complexes for Enhanced Drug Solubility via Hot-Melt Extrusion: A Quality by Design Approach

Munnangi,

Youssef,

Narala

et al. 2023

Pharmaceutics

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Conventional cyclodextrin complexation enhances the solubility of poorly soluble drugs but is solvent-intensive and environmentally unfavorable. This study evaluated solvent-free hot-melt extrusion (HME) for forming cyclodextrin inclusion complexes to improve the solubility and dissolution of ibuprofen (IBU). Molecular docking confirmed IBU’s hosting in Hydroxypropyl-β-cyclodextrin (HPβ-CD), while phase solubility revealed its complex stoichiometry and stability. In addition, an 11 mm twin-screw co-rotating extruder with PVP VA-64 as an auxiliary substance aided the complex formation and extrusion. Using QbD and the Box–Behnken design, we studied variables (barrel temperature, screw speed, and polymer concentration) and their impact on solubility and dissolution. The high polymer concentration and high screw speeds positively affected the dependent variables. However, higher temperatures had a negative effect. The lowest barrel temperature set near the Tg of the polymer, when combined with high polymer concentrations, resulted in high torques in HME and halted the extrusion process. Therefore, the temperature and polymer concentration should be selected to provide sufficient melt viscosities to aid the complex formation and extrusion process. Studies such as DSC and XRD revealed the amorphous conversion of IBU, while the inclusion complex formation was demonstrated by ATR and NMR studies. The dissolution of ternary inclusion complexes (TIC) produced from HME was found to be ≥85% released within 30 min. This finding implied the high solubility of IBU, according to the US FDA 2018 guidance for highly soluble compounds containing immediate-release solid oral dosage forms. Overall, the studies revealed the effect of various process parameters on the formation of CD inclusion complexes via HME.

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Development, optimization and in-vivo evaluation of cyanocobalamin loaded orodispersible films using hot-melt extrusion technology: A quality by design (QbD) approach

Cited by 19 publications

References 37 publications

A review on orodispersible drug delivery system

A review on orodispersible drug delivery system

Cellulose- and Saccharide-Based Orally Dispersible Thin Films Transform the Solid States and Dissolution Characteristics of Poorly Soluble Curcumin

Continuous Manufacturing of Solvent-Free Cyclodextrin Inclusion Complexes for Enhanced Drug Solubility via Hot-Melt Extrusion: A Quality by Design Approach

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