Comparison of immediate and sustained release formulations of lithium salts

Pompili, Maurizio; Magistri, Carlo; Mellini, Cristiano; Sarli, Giuseppe; Baldessarini, Ross J.

doi:10.1080/09540261.2022.2122706

Cited by 5 publications

(6 citation statements)

References 21 publications

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“…The slower increase in serum lithium concentrations and the lower Cmax (maximum concentration of drug detected in the blood) with SR formulations compared to IR lithium formulations translate into a reduced rate or less severity for some lithium-related adverse events, including tremors, upper gastrointestinal cramps, nausea, rash, cognitive obtundation, polyuria; a close relationship between changes in blood lithium levels and frequency and severity of side effects has been recently highlighted. Pompili et al [88] found that SR lithium salts offer clinical advantages over IR formulations in terms of more stable circulating concentrations of lithium, less adverse impact on renal function, low incidence of adverse neurological effects (including cognitive impairment and tremor), low subjectively unpleasant adverse effects such as fatigue and weight-gain, and greater treatment adherence.…”

Section: Myth 5: Different Formulations Of Lithium Do Not Modify Its ...mentioning

confidence: 99%

“…Furthermore, the use of lithium as a lethal mean for suicide has not received support, as data indicate that mortality from an overdose of lithium is similar to that associated with other psychotropic drugs, or even less, as well as suicidal gestures with lithium are uncommon, or even absent, during long-term lithium treatment [98]. The availability of slow-release formulation may reduce side effects and improve adherence [88,97].…”

Section: Myth 6: No Drug Has An Antisuicidal Effect Fact 6: Lithium T...mentioning

confidence: 99%

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Facts and myths about the use of lithium for bipolar disorder in routine clinical practice: an expert consensus paper

Fiorillo,

Sampogna,

Albert

et al. 2023

Ann Gen Psychiatry

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Background Bipolar disorder is one of the most burdensome severe mental disorders, characterized by high levels of personal and social disability. Patients often need an integrated pharmacological and non-pharmacological approach. Lithium is one of the most effective treatments available not only in psychiatry, but in the whole medicine, and its clinical efficacy is superior to that of other mood stabilizers. However, a declining trend on lithium prescriptions has been observed worldwide in the last 20 years, supporting the notion that lithium is a ‘forgotten drug’ and highlighting that the majority of patients with bipolar disorder are missing out the best available pharmacological option. Based on such premises, a narrative review has been carried out on the most common “misconceptions” and “stereotypes” associated with lithium treatment; we also provide a list of “good reasons” for using lithium in ordinary clinical practice to overcome those false myths. Main text A narrative search of the available literature has been performed entering the following keywords: “bipolar disorder”, “lithium”, “myth”, “mythology”, “pharmacological treatment”, and “misunderstanding”. The most common false myths have been critically revised and the following statements have been proposed: (1) Lithium should represent the first choice for the treatment of patients with bipolar disorder; (2) lithium treatment is effective in different patients’ groups suffering from bipolar disorder; (3) Drug–drug interaction risk can be easily managed during lithium treatment; (4) The optimal management of lithium treatment includes periodical laboratory tests; (5) Slow-release lithium formulation has advantages compared to immediate release formulation; (6) Lithium treatment has antisuicidal properties; (7) Lithium can be carefully managed during pregnancy. Conclusions In recent years, a discrepancy between evidence-based recommendations and clinical practice in using lithium treatment for patients with bipolar disorder has been highlighted. It is time to disseminate clear and unbiased information on the clinical efficacy, effectiveness, tolerability and easiness to use of lithium treatment in patients with bipolar disorder. It is necessary to reinvigorate the clinical and academic discussion about the efficacy of lithium, to counteract the decreasing prescription trend of one of the most effective drugs available in the whole medicine.

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Section: Myth 5: Different Formulations Of Lithium Do Not Modify Its ...mentioning

confidence: 99%

Section: Myth 6: No Drug Has An Antisuicidal Effect Fact 6: Lithium T...mentioning

confidence: 99%

Facts and myths about the use of lithium for bipolar disorder in routine clinical practice: an expert consensus paper

Fiorillo,

Sampogna,

Albert

et al. 2023

Ann Gen Psychiatry

Self Cite

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“…These systems are particularly beneficial for drugs like codeine [ 3 ], hydromorphone [ 4 ], and morphine [ 5 ] as they reduce the frequency of dosing, thereby improving patient adherence, reducing side effects, and enhancing drug efficacy [ 6 ]. CDDSs are vital for drugs with a narrow therapeutic index, such as theophylline (THN) [ 7 ], and lithium [ 8 ], ensuring the maintenance of therapeutic levels and optimal patient outcomes [ 4 , 9 , 10 ]. Therefore, the development of high-quality controlled-release (CR) medications is crucial in optimizing treatment efficacy and minimizing adverse effects [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

“…The CR dosage form is recommended for THN due to its rapid absorption, narrow therapeutic window (5 to 20 mg/mL), and short half-life (3-8 h) [20,22]. line (THN) [7], and lithium [8], ensuring the maintenance of therapeutic levels and optimal patient outcomes [4,9,10]. Therefore, the development of high-quality controlled-release (CR) medications is crucial in optimizing treatment efficacy and minimizing adverse effects [11,12].…”

Section: Introductionmentioning

confidence: 99%

Effect of Hydration Forms and Polymer Grades on Theophylline Controlled-Release Tablet: An Assessment and Evaluation

Sakkal,

Arafat,

Yuvaraju

et al. 2024

Pharmaceuticals

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Background: Drug release from controlled release delivery systems is influenced by various factors, including the polymer’s grade and the drug’s hydration form. This study aimed to investigate the impact of these factors on the controlled release of theophylline (THN). This research compares the monohydrate form found in branded products with the anhydrous form in generic equivalents, each formulated with different polymer grades. Methods: Quality control assessment was conducted alongside in vitro evaluation, complemented by various analytical techniques such as X-ray diffraction (XRD) and scanning electron microscopy (SEM). Additionally, thermal analyses using differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) were employed. Results: Quality control assessments demonstrated that the generic tablets exhibited lower average weight and resistance force compared to the branded ones. In vitro tests revealed that generic tablets released contents within 120 min, compared to 720 min for the branded counterpart. Characterization using XRD and SEM identified disparities in crystallinity and particle distribution between the three samples. Additionally, the thermal analysis indicated consistent endothermic peaks across all samples, albeit with minor variations in heat flow and decomposition temperatures between the two products. Conclusions: This study demonstrated that variations in polymer grade and hydration form significantly impact THN release.

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“…Lithiumsustained-release preparations with small fluctuations in blood concentration are known to have high tolerability. 8 On the other hand, from the point of view of renal dysfunction, there are still many unknown points about the difference due to the number of divided doses. Previous studies have pointed out that single-dose administration reduces polyuria compared to multiple administrations of sustained-release tablets, 9 and the risk of developing Stage III renal failure is reportedly decreased by a single-dose administration.…”

Section: Introductionmentioning

confidence: 99%

Impact of single versus multiple dose lithium on renal dysfunction in bipolar patients: A retrospective cohort study

Harada,

Kato

2024

PCN Reports

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AimBipolar disorder significantly affects social functioning and maintenance treatment is crucial. Lithium is considered as a first‐line maintenance treatment in all treatment guidelines, but careful administration is necessary due to concerns about renal dysfunction caused by its use. Lithium can be administered in divided doses from two to three times a day or once a day. However, it is controversial which regimen, single or multiple dose, should be recommended in light of adverse effects. This study aims to clarify the difference in renal dysfunction due to the number of divided lithium doses using data from the electronic medical record in a retrospective cohort.MethodsWe targeted 72 patients who were prescribed lithium carbonate for bipolar disorder in the Juntendo University Hospital electronic medical record from April 2021 to March 2023. There were 35 cases in the single‐dose group and 37 cases in the multiple‐dose group. The outcome was the change in creatinine and estimated glomerular filtration rate (eGFR) during the observation period. The effect of the regimen was evaluated using multiple regression analysis.ResultsThere were no significant differences in the change in creatinine and eGFR between the single‐ and the multiple‐dose group, though renal function measured by creatinine and eGFR significantly worsened depending on the duration of treatment or aging.ConclusionThere was no significant difference in renal dysfunction between the single‐dose group and the multiple‐dose group; thus, considering the expected positive effect on adherence, a once‐daily regimen is recommended in maintenance lithium treatment.

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Comparison of immediate and sustained release formulations of lithium salts

Cited by 5 publications

References 21 publications

Facts and myths about the use of lithium for bipolar disorder in routine clinical practice: an expert consensus paper

Facts and myths about the use of lithium for bipolar disorder in routine clinical practice: an expert consensus paper

Effect of Hydration Forms and Polymer Grades on Theophylline Controlled-Release Tablet: An Assessment and Evaluation

Impact of single versus multiple dose lithium on renal dysfunction in bipolar patients: A retrospective cohort study

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