Physicochemical and Microbiological Stability of Two Oral Solutions of Methadone Hydrochloride 10 mg/mL
In this article, we studied physicochemical and microbiological stability and determined the beyond-use date of two oral solutions of methadone in three storage conditions. For this, two oral solutions of methadone (10 mg/mL) were prepared, with and without parabens, as preservatives. They were packed in amber glass vials kept unopened until the day of the test, and in a multi-dose umber glass bottle opened daily. They were stored at 5 ± 3 °C, 25 ± 2 °C and 40 ± 2 °C. pH, clarity, and organoleptic characteristics were obtained. A stability-indicating high-performance liquid chromatography method was used to determine methadone. Microbiological quality was studied and antimicrobial effectiveness testing was also determined following European Pharmacopoeia guidelines. Samples were analyzed at days 0, 7, 14, 21, 28, 42, 56, 70, and 91 in triplicate. After 91 days of storage, pH remained stable at about 6.5-7 in the two solutions, ensuring no risk of methadone precipitation. The organoleptic characteristics remained stable (colorless, odorless, and bitter taste). The absence of particles was confirmed. No differences were found with the use of preservatives. Methadone concentration remained within 95-105% in all samples. No microbial growth was observed. Hence, the two oral methadone solutions were physically and microbiologically stable at 5 ± 3 °C, 25 ± 2 °C, and 40 ± 2 °C for 91 days in closed and opened amber glass bottles.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:27 |
|---|---|
| Enthalten in: |
Molecules (Basel, Switzerland) - 27(2022), 9 vom: 28. Apr. |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Álvaro-Alonso, Elena Alba [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Amber |
|---|
| Anmerkungen: |
Date Completed 19.05.2022 Date Revised 16.07.2022 published: Electronic Citation Status MEDLINE |
|---|
| doi: |
10.3390/molecules27092812 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM340891106 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM340891106 | ||
| 003 | DE-627 | ||
| 005 | 20231226010515.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.3390/molecules27092812 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1136.xml |
| 035 | |a (DE-627)NLM340891106 | ||
| 035 | |a (NLM)35566167 | ||
| 035 | |a (PII)2812 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Álvaro-Alonso, Elena Alba |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Physicochemical and Microbiological Stability of Two Oral Solutions of Methadone Hydrochloride 10 mg/mL |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 19.05.2022 | ||
| 500 | |a Date Revised 16.07.2022 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a In this article, we studied physicochemical and microbiological stability and determined the beyond-use date of two oral solutions of methadone in three storage conditions. For this, two oral solutions of methadone (10 mg/mL) were prepared, with and without parabens, as preservatives. They were packed in amber glass vials kept unopened until the day of the test, and in a multi-dose umber glass bottle opened daily. They were stored at 5 ± 3 °C, 25 ± 2 °C and 40 ± 2 °C. pH, clarity, and organoleptic characteristics were obtained. A stability-indicating high-performance liquid chromatography method was used to determine methadone. Microbiological quality was studied and antimicrobial effectiveness testing was also determined following European Pharmacopoeia guidelines. Samples were analyzed at days 0, 7, 14, 21, 28, 42, 56, 70, and 91 in triplicate. After 91 days of storage, pH remained stable at about 6.5-7 in the two solutions, ensuring no risk of methadone precipitation. The organoleptic characteristics remained stable (colorless, odorless, and bitter taste). The absence of particles was confirmed. No differences were found with the use of preservatives. Methadone concentration remained within 95-105% in all samples. No microbial growth was observed. Hence, the two oral methadone solutions were physically and microbiologically stable at 5 ± 3 °C, 25 ± 2 °C, and 40 ± 2 °C for 91 days in closed and opened amber glass bottles | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a drug compounding | |
| 650 | 4 | |a high performance liquid chromatography | |
| 650 | 4 | |a methadone hydrochloride | |
| 650 | 4 | |a microbiology | |
| 650 | 4 | |a pharmaceutical solutions | |
| 650 | 4 | |a stability study | |
| 650 | 7 | |a Amber |2 NLM | |
| 650 | 7 | |a Solutions |2 NLM | |
| 650 | 7 | |a Methadone |2 NLM | |
| 650 | 7 | |a UC6VBE7V1Z |2 NLM | |
| 700 | 1 | |a Lorenzo, Ma Paz |e verfasserin |4 aut | |
| 700 | 1 | |a Gonzalez-Prieto, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Izquierdo-García, Elsa |e verfasserin |4 aut | |
| 700 | 1 | |a Escobar-Rodríguez, Ismael |e verfasserin |4 aut | |
| 700 | 1 | |a Aguilar-Ros, Antonio |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Molecules (Basel, Switzerland) |d 2004 |g 27(2022), 9 vom: 28. Apr. |w (DE-627)NLM172073448 |x 1420-3049 |7 nnns |
| 773 | 1 | 8 | |g volume:27 |g year:2022 |g number:9 |g day:28 |g month:04 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3390/molecules27092812 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 27 |j 2022 |e 9 |b 28 |c 04 | ||