دورية أكاديمية
Development, Quality by Design-Based Optimization, and Stability Assessment of Oral Liquid Formulations Containing Baclofen for Hospital Use.
| العنوان: | Development, Quality by Design-Based Optimization, and Stability Assessment of Oral Liquid Formulations Containing Baclofen for Hospital Use. |
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| المؤلفون: | de Saldanha Simon E; Pharmaceutical Sciences Graduate Program, Federal University of Rio Grande Do Sul (UFRGS), 2752 Ipiranga Ave, Porto Alegre, RS, Brazil. elisa_saldanha@yahoo.com.br.; College of Pharmacy, Federal University of Rio Grande Do Sul (UFRGS), 2752 Ipiranga Ave., Laboratory 402, Santana, Porto Alegre, RS, 90610-000, Brazil. elisa_saldanha@yahoo.com.br., Wingert NR; College of Pharmacy, Federal University of Bahia (UFBA), 147 Barão Do Jeremoabo St, Salvador, BA, Brazil., Gobetti C; Pharmaceutical Sciences Graduate Program, Federal University of Rio Grande Do Sul (UFRGS), 2752 Ipiranga Ave, Porto Alegre, RS, Brazil., Primieri GB; College of Pharmacy, Federal University of Rio Grande Do Sul (UFRGS), 2752 Ipiranga Ave., Laboratory 402, Santana, Porto Alegre, RS, 90610-000, Brazil., Ayres MV; Semi Industrial Pharmacy, Hospital de Clínicas de Porto Alegre (HCPA), 2350 Ramiro Barcelos St, Porto Alegre, RS, Brazil., de Almeida SHO; Semi Industrial Pharmacy, Hospital de Clínicas de Porto Alegre (HCPA), 2350 Ramiro Barcelos St, Porto Alegre, RS, Brazil., Volpato NM; Pharmaceutical Sciences Graduate Program, Federal University of Rio Grande Do Sul (UFRGS), 2752 Ipiranga Ave, Porto Alegre, RS, Brazil., Steppe M; Pharmaceutical Sciences Graduate Program, Federal University of Rio Grande Do Sul (UFRGS), 2752 Ipiranga Ave, Porto Alegre, RS, Brazil. |
| المصدر: | AAPS PharmSciTech [AAPS PharmSciTech] 2022 Nov 16; Vol. 23 (8), pp. 301. Date of Electronic Publication: 2022 Nov 16. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932 (Electronic) Linking ISSN: 15309932 NLM ISO Abbreviation: AAPS PharmSciTech Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: New York : Springer Original Publication: Arlington, VA : American Association of Pharmaceutical Scientists, c2000- |
| مواضيع طبية MeSH: | Baclofen* , Excipients*/chemistry, Humans ; Child ; Drug Stability ; Drug Compounding ; Tablets ; Hospitals |
| مستخلص: | The absence of oral liquid pharmaceutical forms appropriate for use in pediatric and adult patients with difficulty swallowing is a public health problem, especially in the hospital context. Baclofen is a muscle relaxant of choice for treating spasticity, generally marketed only in tablet form, highlighting the need for liquid formulations to facilitate dose adjustment, administration, and swallowing. The present study aimed to develop oral liquid formulations containing baclofen, optimize them through the quality by design approach, and evaluate their physicochemical and microbiological stability. Preformulation and preliminary stability studies were carried out for the development of formulations. Experimental screening and optimization designs resulted in eleven experiments for each step that were evaluated for 28 days. A stability-indicating method by high-performance liquid chromatography presented linearity, low limits of detection and quantification, precision, accuracy, and robustness. The experimental design led to two optimized formulations containing baclofen, glycerin, potassium sorbate, citric acid, ultrapure water, flavor, and sucrose syrup or sodium carboxymethylcellulose solution as a vehicle, the last one with sucralose as a sweetener. The formulations were placed in amber glass flasks and subjected to a physicochemical and microbiological stability study. Both formulations showed physicochemical and microbiological stability when stored at room temperature and refrigerated for 84 days. The results of this study may serve as a reference in the preparation of liquid oral formulations containing baclofen in the hospital routine and collaborate with the safety and adherence to the treatment of adult and pediatric patients. (© 2022. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.) |
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| فهرسة مساهمة: | Keywords: HPLC; baclofen; liquid formulation; quality by design; stability |
| المشرفين على المادة: | H789N3FKE8 (Baclofen) 0 (Tablets) 0 (Excipients) |
| تواريخ الأحداث: | Date Created: 20221117 Date Completed: 20221121 Latest Revision: 20221128 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1208/s12249-022-02447-x |
| PMID: | 36385217 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1530-9932 |
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| DOI: | 10.1208/s12249-022-02447-x |