Pharmaceutical and Clinical Assessment of Multi-source Tegretol Sold in Egypt DOI Open Access

Sarah K Amer,

H. I. El-Deeb,

AG Eshra

и другие.

International Journal of Pharmaceutical Quality Assurance, Год журнала: 2023, Номер 14(03), С. 675 - 686

Опубликована: Сен. 25, 2023

across generic Narrow therapeutic index (NTI) medications compared to brands. However, little attention has been given possible inequality within the same brand due transportation and storage conditions, production site, manufacturing condition, product specification requested by different countries. Market surveys shown that Egypt is one of countries suffering from this problem, which consequently augments need for comparing evaluating products marketed under name, manufactured in its own licensing trademark™ sold Egypt. This work studies drug carbamazepine (CBZ) available as Tegretol® tablets used an oral first-line anti-epileptic (AED). Objectives: The present investigate evaluate pharmaceutical quality clinical efficacy Tegretol®, obtained Saudi Arabia being 2020 21. Methods: In-vitro testing included potency uniformity content tests performed according USP 2019 monograph. Dissolution rates were also carried adopting dissolution test drug. Studies stability adjusted at 25°C/65% RH, 45°C/75% RH 10°C/15% RH. was studied pharmacokinetics parameters blood sodium level during six months therapy. Results: Variability between multisource ensured. Potency results revealed statistically significant difference sources. Also, variations recognized both sources when dissolved HCL/KCL, Acetate Phosphate Buffer media. Dissimilarities hardness friability testing. Furthermore, a pharmacokinetically pharmacodynamically inequivalence Hence, hyponatremia more prominent patients receiving Arabian taking Egyptian Tegretol®. Conclusion: Interchangeability multi-source Tegretol should be limited.

Язык: Английский

Challenges for switching central nervous system and psychiatric medication products: A review of the literature DOI Creative Commons
Ric M. Procyshyn, Martin A. Katzman, Howard C. Margolese

и другие.

Journal of Psychopharmacology, Год журнала: 2025, Номер 39(2), С. 81 - 91

Опубликована: Янв. 31, 2025

Switching between versions of medication products happens commonly despite challenges in achieving bioequivalence and therapeutic equivalence. Central nervous system psychiatric drugs, especially those that are technically demanding to manufacture have complex pharmacokinetic properties, such as long-acting injectables (LAIs), pose particular safe efficacious drug switching. To assess whether drugs deemed "bioequivalent" truly interchangeable We assessed the published literature from January 2017 through June 2023 on PubMed using MeSH terms "drugs, generic" OR "equivalency, combined with for different classes. While most studies returned search found switching was clinically comparable, data classes other than primarily indicated treatment seizure disorder were sparse. Some also provided evidence real-world outcomes adherence hospitalizations may be affected by In addition, a review testing guidance showed inconsistency across agencies lack product-specific Health Canada, which raises questions about potential claims more LAIs. Overall, given difficulty treating mental health disorders, prescribers should cautious when formulations patient who has been stabilized drug.

Язык: Английский

Процитировано

0
Effects of Generic Exchange of Levodopa Medication in Patients With Parkinson Disease DOI
Johanna Weitzel, Klaus Langer, Olaf Rose

и другие.

Journal of Patient Safety, Год журнала: 2022, Номер 18(7), С. 704 - 710

Опубликована: Май 4, 2022

Objectives Generic exchange is common practice in most healthcare systems. This study investigated how patients with Parkinson disease (PD) perceived a switch of their levodopa medication and the resulting effects on PD symptoms. Methods A questionnaire was developed, piloted, finally distributed to 13,857 members national patient support group. It designed be completed by pharmacies. χ 2 tests for independence statistics or without Monte Carlo simulation were performed. Cramér φ V calculated. McNemar test used investigate whether generic levodopa-containing had an impact Results Analyses done 410 finalized respondents questionnaires. More than half responders 75 years older rated themselves Hoehn Yahr stages 3 5. Most confused change medication. total 54.7% switchers (n = 148) reported swallowing difficulties medication, which significantly more frequent nonswitchers (37.3% 204, P 0.001). Adverse related 26.6% all (switchback rate, 20.5%). The at higher affected greater extend. Conclusions Patients, who experienced any brand frequently expressed distrust confusion. Swallowing negative symptoms problems, pronounced advanced stages. remains unclear detrimental therapy caused nocebo effect.

Язык: Английский

Процитировано

2
Different dissolution conditions affect stability and dissolution profiles of bioequivalent levodopa-containing oral dosage forms DOI
Johanna Weitzel,

Angelika Wünsch,

Olaf Rose

и другие.

International Journal of Pharmaceutics, Год журнала: 2022, Номер 629, С. 122401 - 122401

Опубликована: Ноя. 14, 2022

Язык: Английский

Процитировано

1
Attitudes towards the switching of anti-epileptic medications in pharmacies: the patients’ perspective DOI Open Access

Milena Bożek,

Iwona Kurkowska‐Jastrzębska, Ewa Krzystanek

и другие.

Postępy Psychiatrii i Neurologii, Год журнала: 2023, Номер 32(1), С. 12 - 17

Опубликована: Янв. 1, 2023

ENWEndNote BIBJabRef, Mendeley RISPapers, Reference Manager, RefWorks, Zotero AMA Bożek M, Kurkowska-Jastrzebska I, Krzystanek E, Bienkowski P, Konopko Sienkiewicz-Jarosz H. Attitudes towards the switching of anti-epileptic medications in pharmacies: patients’ perspective. Advances Psychiatry and Neurology/Postępy Psychiatrii i Neurologii. 2023. doi:10.5114/ppn.2023.126329. APA Bożek, M., Kurkowska-Jastrzebska, I., Krzystanek, E., Bienkowski, P., Konopko, & Sienkiewicz-Jarosz, (2023). https://doi.org/10.5114/ppn.2023.126329 Chicago Milena, Iwona Ewa Przemyslaw Magdalena Halina Sienkiewicz-Jarosz. "Attitudes perspective". Harvard MLA Milena et al. perspective." Neurologii, Vancouver

Процитировано

0
Opinion of Polish Patients with Epilepsy on Generic Medications DOI Open Access
Katarzyna Swakowska, Urszula Religioni, Anna Staniszewska

и другие.

Healthcare, Год журнала: 2023, Номер 11(20), С. 2717 - 2717

Опубликована: Окт. 12, 2023

The majority of medicines used in Poland are generic drugs and substitutions the originals. objective this study was to obtain information on current knowledge about among Polish patients with epilepsy. conducted based a self-developed questionnaire. questionnaire consisted 26 questions, including questions regarding respondents' generics, their previous experience, factors behind these choices. Overall, 1220 questionnaires were analyzed. Among all patients, 66.4% reportedly had heard generics. Of these, 61.5% past. A significant proportion participants never been recommended switch medicine by healthcare professional (23% physicians 13.9% pharmacists). Statistically, relevant differences observed kind level education, place residence, net income per household. Significant gaps identified perceptions medicines, especially relation efficacy safety. Efforts must be directed towards increasing public awareness there should also focus educating medicines.

Язык: Английский

Процитировано

0
Pharmaceutical and Clinical Assessment of Multi-source Tegretol Sold in Egypt DOI Open Access

Sarah K Amer,

H. I. El-Deeb,

AG Eshra

и другие.

International Journal of Pharmaceutical Quality Assurance, Год журнала: 2023, Номер 14(03), С. 675 - 686

Опубликована: Сен. 25, 2023

across generic Narrow therapeutic index (NTI) medications compared to brands. However, little attention has been given possible inequality within the same brand due transportation and storage conditions, production site, manufacturing condition, product specification requested by different countries. Market surveys shown that Egypt is one of countries suffering from this problem, which consequently augments need for comparing evaluating products marketed under name, manufactured in its own licensing trademark™ sold Egypt. This work studies drug carbamazepine (CBZ) available as Tegretol® tablets used an oral first-line anti-epileptic (AED). Objectives: The present investigate evaluate pharmaceutical quality clinical efficacy Tegretol®, obtained Saudi Arabia being 2020 21. Methods: In-vitro testing included potency uniformity content tests performed according USP 2019 monograph. Dissolution rates were also carried adopting dissolution test drug. Studies stability adjusted at 25°C/65% RH, 45°C/75% RH 10°C/15% RH. was studied pharmacokinetics parameters blood sodium level during six months therapy. Results: Variability between multisource ensured. Potency results revealed statistically significant difference sources. Also, variations recognized both sources when dissolved HCL/KCL, Acetate Phosphate Buffer media. Dissimilarities hardness friability testing. Furthermore, a pharmacokinetically pharmacodynamically inequivalence Hence, hyponatremia more prominent patients receiving Arabian taking Egyptian Tegretol®. Conclusion: Interchangeability multi-source Tegretol should be limited.

Язык: Английский

Процитировано

0