Influence of Polyvinyl Alcohol (PVA) on PVA-Poly- N -hydroxyethyl-aspartamide (PVA-PHEA) Microcrystalline Solid Dispersi
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Research Article Influence of Polyvinyl Alcohol (PVA) on PVA-Poly-N-hydroxyethyl-aspartamide (PVA-PHEA) Microcrystalline Solid Dispersion Films Zahra Al-Sahaf,1 Bahijja Raimi-Abraham,2 Mariano Licciardi,2 and Laura Modica de Mohac1,2,3
Received 7 July 2020; accepted 2 September 2020 Abstract. This study was conducted to formulate buccal films consisting of polyvinyl alcohol
(PVA) and poly-N-hydroxyethyl-aspartamide (PHEA), to improve the dissolution of the drug through the oral mucosa. Ibuprofen sodium salt was used as a model drug, and the buccal film was expected to enhance its dissolution rate. Two different concentrations of PVA (5% w/v and 7.5% w/v) were used. Solvent casting was used to prepare films, where a solution consisting of drug and polymer was cast and allowed to dry. Attenuated total reflection Fourier transform infrared spectroscopy (ATR-FTIR), differential scanning calorimetry (DSC), and scanning electron microscopy (SEM) were used to investigate the properties of films. In vitro dissolution studies were also conducted to investigate drug release. SEM studies showed that films containing a higher concentration of PVA had larger particles in microrange. FTIR studies confirmed the presence of the drug in films and indicated that ibuprofen sodium did not react with polymers. DSC studies confirmed the crystalline form of ibuprofen sodium when incorporated within films. In vitro dissolution studies found that the dissolution percentage of ibuprofen sodium alone was increased when incorporated within the film from 59 to 74%. This study led to the development of solid microcrystalline dispersion as a buccal film with a faster dissolution rate than the drug alone overcoming problem of poor solubility. KEY WORDS: buccal film; PVA; PHEA; ibuprofen sodium; crystalline.
INTRODUCTION Tablets represent the most common dosage form available in the market, but they present both pharmaceutical and clinical issues (1). Tablet compression is compromised when using a hygroscopic drug with low density (2,3). Moreover, drugs with low solubility, which are 60% of marketed compounds, would have a low dissolution into the gastrointestinal tract, causing a reduced bioavailability (4). Even if an oral tablet denotes easy administration for most of the patients, it represents a cause of discomfort for patients with swallowing aversion, pediatric and geriatric population, or with altered absorption diseases that do not benefit from conventional oral route (5–7). Some of the factors associated with low compliance are side effects experienced by the patient and the complexity of treatment, such as multiple dosing times every day (8). Therefore, tablets are not always preferred route of administration.
1
King’s College London, London, UK. University of Study of Palermo, Palermo, Italy. 3 To whom correspondence should be addressed. (e–mail: [email protected]) 2
Oral cavity film administration has recently emerged as a promising alternative to solid dosage forms (9). Drug delivery via the oral cavity can take place by placin
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