Formulation and characterization of bilastine -  cyclodextrin inclusion complex loaded as an oral fast  dissolving film

Eman Al-khedairy

Makale detayları

Formulation and characterization of bilastine - cyclodextrin inclusion complex loaded as an oral fast dissolving film

Yazarlar:

Eman Al-khedairy

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Delivery Technologies

Dergi:

Journal of Research in Pharmacy Vol.29 Issue 1, pp.370-377

Belge Tipi:

Makale

Yayın Tarihi:

3/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001339611

pISSN:

2630-6344

Anahtar kelimeler:

Özet:

 Oral fast dissolving films OFDFs are the most innovative oral solid pharmaceutical dosage form, especially for elderly and pediatric patients who may have dysphagia. Bilastine BLA, is a second  generation antihistamine used to manage allergy symptoms; it is very slightly soluble in water. The main objective of this research was to enhance the solubility and dissolution rate of BLA by complexation technique. Ternary complex of BLA: methyl β- cyclodextrin M-β-CD: soluplus 5 ww was prepared via solvent evaporation technique as a trial to enhance its solubility to be prepared as OFDF by incorporated into aqueous polymeric solution. Seven formulas of OFDFs were prepared using the solvent casting method using Polyvinyl alcohol, Hydroxy propyl methyl cellulose E5, and Pullulan as polymers that form film, PEG 400, and glycerin as plasticizers. The prepared films were estimated for their physical, and mechanical properties, drug content, and dissolution rate. The results showed that,the prepared complex enhanced the solubility of the BLA in water 11 times more than the pure BLA in distilled water and it was easily utilized for the preparation of the OFDFs. The PVA-based formulation in the presence of glycerin as a plasticizer F4, showed a homogenous clear film with accepted folding endurance 300, the shortest disintegration time 16.66 seconds, and complete release within five minutes. In conclusion, complexation of BLA with M-β CD was an efficient method for enhancing its solubility and dissolution rate to be easily prepared as OFDF with acceptable physical properties.

 Oral fast dissolving films OFDFs are the most innovative oral solid pharmaceutical dosage form, especially for elderly and pediatric patients who may have dysphagia. Bilastine BLA, is a second  generation antihistamine used to manage allergy symptoms; it is very slightly soluble in water. The main objective of this research was to enhance the solubility and dissolution rate of BLA by complexation technique. Ternary complex of BLA: methyl β- cyclodextrin M-β-CD: soluplus 5 ww was prepared via solvent evaporation technique as a trial to enhance its solubility to be prepared as OFDF by incorporated into aqueous polymeric solution. Seven formulas of OFDFs were prepared using the solvent casting method using Polyvinyl alcohol, Hydroxy propyl methyl cellulose E5, and Pullulan as polymers that form film, PEG 400, and glycerin as plasticizers. The prepared films were estimated for their physical, and mechanical properties, drug content, and dissolution rate. The results showed that,the prepared complex enhanced the solubility of the BLA in water 11 times more than the pure BLA in distilled water and it was easily utilized for the preparation of the OFDFs. The PVA-based formulation in the presence of glycerin as a plasticizer F4, showed a homogenous clear film with accepted folding endurance 300, the shortest disintegration time 16.66 seconds, and complete release within five minutes. In conclusion, complexation of BLA with M-β CD was an efficient method for enhancing its solubility and dissolution rate to be easily prepared as OFDF with acceptable physical properties.

 Oral fast dissolving films OFDFs are the most innovative oral solid pharmaceutical dosage form, especially for elderly and pediatric patients who may have dysphagia. Bilastine BLA, is a second  generation antihistamine used to manage allergy symptoms; it is very slightly soluble in water. The main objective of this research was to enhance the solubility and dissolution rate of BLA by complexation technique. Ternary complex of BLA: methyl β- cyclodextrin M-β-CD: soluplus 5 ww was prepared via solvent evaporation technique as a trial to enhance its solubility to be prepared as OFDF by incorporated into aqueous polymeric solution. Seven formulas of OFDFs were prepared using the solvent casting method using Polyvinyl alcohol, Hydroxy propyl methyl cellulose E5, and Pullulan as polymers that form film, PEG 400, and glycerin as plasticizers. The prepared films were estimated for their physical, and mechanical properties, drug content, and dissolution rate. The results showed that,the prepared complex enhanced the solubility of the BLA in water 11 times more than the pure BLA in distilled water and it was easily utilized for the preparation of the OFDFs. The PVA-based formulation in the presence of glycerin as a plasticizer F4, showed a homogenous clear film with accepted folding endurance 300, the shortest disintegration time 16.66 seconds, and complete release within five minutes. In conclusion, complexation of BLA with M-β CD was an efficient method for enhancing its solubility and dissolution rate to be easily prepared as OFDF with acceptable physical properties.

 Oral fast dissolving films OFDFs are the most innovative oral solid pharmaceutical dosage form, especially for elderly and pediatric patients who may have dysphagia. Bilastine BLA, is a second  generation antihistamine used to manage allergy symptoms; it is very slightly soluble in water. The main objective of this research was to enhance the solubility and dissolution rate of BLA by complexation technique. Ternary complex of BLA: methyl β- cyclodextrin M-β-CD: soluplus 5 ww was prepared via solvent evaporation technique as a trial to enhance its solubility to be prepared as OFDF by incorporated into aqueous polymeric solution. Seven formulas of OFDFs were prepared using the solvent casting method using Polyvinyl alcohol, Hydroxy propyl methyl cellulose E5, and Pullulan as polymers that form film, PEG 400, and glycerin as plasticizers. The prepared films were estimated for their physical, and mechanical properties, drug content, and dissolution rate. The results showed that,the prepared complex enhanced the solubility of the BLA in water 11 times more than the pure BLA in distilled water and it was easily utilized for the preparation of the OFDFs. The PVA-based formulation in the presence of glycerin as a plasticizer F4, showed a homogenous clear film with accepted folding endurance 300, the shortest disintegration time 16.66 seconds, and complete release within five minutes. In conclusion, complexation of BLA with M-β CD was an efficient method for enhancing its solubility and dissolution rate to be easily prepared as OFDF with acceptable physical properties.

Makale detayları

Formulation and characterization of bilastine - cyclodextrin inclusion complex loaded as an oral fast dissolving film

Yazarlar:

Eman Al-khedairy

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Delivery Technologies

Dergi:

Journal of Research in Pharmacy Vol.29 Issue 1, pp.370-377

Belge Tipi:

Makale

Yayın Tarihi:

3/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001339611

pISSN:

2630-6344

Bilastine

Cyclodextrin-complex

Methyl-β-cyclodextrin

oral fast- dissolving films

ternary complex

Sayı

Makale detayları

Formulation and characterization of bilastine - cyclodextrin inclusion complex loaded as an oral fast dissolving film

Yazarlar: Eman Al-khedairy

Yayıncı: Marmara University

Ana Başlıklar: Pharmaceutical Delivery Technologies

Dergi: Journal of Research in Pharmacy Vol.29 Issue 1, pp.370-377

Belge Tipi: Makale

Yayın Tarihi: 3/2025

Belge Dili: İngilizce

Document ID (Org No.): 2001339611

pISSN: 2630-6344

Bilastine

Cyclodextrin-complex

Methyl-β-cyclodextrin

oral fast- dissolving films

ternary complex

Sayı

Yazarlar:

Eman Al-khedairy

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Delivery Technologies

Dergi:

Journal of Research in Pharmacy Vol.29 Issue 1, pp.370-377

Belge Tipi:

Makale

Yayın Tarihi:

3/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001339611

pISSN:

2630-6344