pH determination as a quality standard for the elaboration of oral liquid compounding formula
Objective: pH is a critical factor for all those medications prepared as aqueous liquid forms, because it has an impact on the solubility of the molecule, determining the stability of medications, the biological tolerability of the formulation, and the activity of the molecule. The objective of th...
Saved in:
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2018-11-01
|
| Series: | Farmacia Hospitalaria |
| Subjects: | |
| Online Access: | http://www.aulamedica.es/fh/pdf/10932.pdf |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850037772352487424 |
|---|---|
| author | Silvia Vázquez-Blanco Lara González-Freire María Carmen Dávila-Pousa Carlos Crespo-Diz |
| author_facet | Silvia Vázquez-Blanco Lara González-Freire María Carmen Dávila-Pousa Carlos Crespo-Diz |
| author_sort | Silvia Vázquez-Blanco |
| collection | DOAJ |
| description | Objective: pH is a critical factor for all those medications prepared as aqueous liquid forms, because it has an impact on the solubility of the molecule, determining the stability of medications, the biological tolerability of the formulation, and the activity of the molecule. The objective of this study is to determine the optimum pH range for the oral liquid formulations more frequently prepared at the Pharmacy Unit, in order to standardize and incorporate said value into the standard protocols of action as a quality control criterion.
Method: The study was conducted in three stages. The first stage consisted in a retrospective study of the records of preparation of those oral liquid formulations prepared at least 5 times since January, 2015 to December, 2016, in our Pharmacy Unit; the main value and standard deviation of the pH values recorded for each formulation were calculated. In a second stage, there was a bibliographic search in order to understand the pH for the maximum stability of the molecule, and to confirm if this characteristic was recorded as a requirement for quality control in the procedures described in the formulation guidelines. In the third stage, it was confirmed if the pH values determined coincided with the maximum stability pH described in literature, and acceptance ranges were established.
Results: In total, 31 formulations were reviewed (14 solutions / 17 suspensions). The maximum stability pH value was known for 19 (61.3%) of the molecules and/or oral liquid formulations evaluated; 15 (78.9%) of these were within this range, and the remaining 4 (21.1%) presented a standard deviation of ± 0.5 regarding the pH value referenced in the bibliography. The pH range for the same standard work procedure ranged between 0.32 and 1.51. An acceptance pH range of ± 0.75 was determined as quality control.
Conclusions: An optimal pH range has been determined for the 31 oral liquid formulations more widely prescribed in our hospital. This characteristic should be part of the galenic validation for these preparations, as well as of its routine quality control, in order to ensure their quality and efficacy. |
| format | Article |
| id | doaj-art-a6da9961a4934e5ea7faec615bdaa7e6 |
| institution | DOAJ |
| issn | 1130-6343 2171-8695 |
| language | English |
| publishDate | 2018-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Farmacia Hospitalaria |
| spelling | doaj-art-a6da9961a4934e5ea7faec615bdaa7e62025-08-20T02:56:46ZengElsevierFarmacia Hospitalaria1130-63432171-86952018-11-0142622122710.7399/fh.10932pH determination as a quality standard for the elaboration of oral liquid compounding formulaSilvia Vázquez-Blanco 0Lara González-Freire 1María Carmen Dávila-Pousa 2Carlos Crespo-Diz 3Pharmacy Unit. Complejo Hospitalario Universitario de Pontevedra, Pontevedra, SpainPharmacy Unit. Complejo Hospitalario Universitario de Pontevedra, Pontevedra, SpainPharmacy Unit. Complejo Hospitalario Universitario de Pontevedra, Pontevedra. SpainPharmacy Unit. Complejo Hospitalario Universitario de Pontevedra, Pontevedra. SpainObjective: pH is a critical factor for all those medications prepared as aqueous liquid forms, because it has an impact on the solubility of the molecule, determining the stability of medications, the biological tolerability of the formulation, and the activity of the molecule. The objective of this study is to determine the optimum pH range for the oral liquid formulations more frequently prepared at the Pharmacy Unit, in order to standardize and incorporate said value into the standard protocols of action as a quality control criterion. Method: The study was conducted in three stages. The first stage consisted in a retrospective study of the records of preparation of those oral liquid formulations prepared at least 5 times since January, 2015 to December, 2016, in our Pharmacy Unit; the main value and standard deviation of the pH values recorded for each formulation were calculated. In a second stage, there was a bibliographic search in order to understand the pH for the maximum stability of the molecule, and to confirm if this characteristic was recorded as a requirement for quality control in the procedures described in the formulation guidelines. In the third stage, it was confirmed if the pH values determined coincided with the maximum stability pH described in literature, and acceptance ranges were established. Results: In total, 31 formulations were reviewed (14 solutions / 17 suspensions). The maximum stability pH value was known for 19 (61.3%) of the molecules and/or oral liquid formulations evaluated; 15 (78.9%) of these were within this range, and the remaining 4 (21.1%) presented a standard deviation of ± 0.5 regarding the pH value referenced in the bibliography. The pH range for the same standard work procedure ranged between 0.32 and 1.51. An acceptance pH range of ± 0.75 was determined as quality control. Conclusions: An optimal pH range has been determined for the 31 oral liquid formulations more widely prescribed in our hospital. This characteristic should be part of the galenic validation for these preparations, as well as of its routine quality control, in order to ensure their quality and efficacy.http://www.aulamedica.es/fh/pdf/10932.pdfDrug compoundingDrug stability; pHQuality controlQuality indicatorPharmaceutical formulary |
| spellingShingle | Silvia Vázquez-Blanco Lara González-Freire María Carmen Dávila-Pousa Carlos Crespo-Diz pH determination as a quality standard for the elaboration of oral liquid compounding formula Farmacia Hospitalaria Drug compounding Drug stability ; pH Quality control Quality indicator Pharmaceutical formulary |
| title | pH determination as a quality standard for the elaboration of oral liquid compounding formula |
| title_full | pH determination as a quality standard for the elaboration of oral liquid compounding formula |
| title_fullStr | pH determination as a quality standard for the elaboration of oral liquid compounding formula |
| title_full_unstemmed | pH determination as a quality standard for the elaboration of oral liquid compounding formula |
| title_short | pH determination as a quality standard for the elaboration of oral liquid compounding formula |
| title_sort | ph determination as a quality standard for the elaboration of oral liquid compounding formula |
| topic | Drug compounding Drug stability ; pH Quality control Quality indicator Pharmaceutical formulary |
| url | http://www.aulamedica.es/fh/pdf/10932.pdf |
| work_keys_str_mv | AT silviavazquezblanco phdeterminationasaqualitystandardfortheelaborationoforalliquidcompoundingformula AT laragonzalezfreire phdeterminationasaqualitystandardfortheelaborationoforalliquidcompoundingformula AT mariacarmendavilapousa phdeterminationasaqualitystandardfortheelaborationoforalliquidcompoundingformula AT carloscrespodiz phdeterminationasaqualitystandardfortheelaborationoforalliquidcompoundingformula |