Pharmacoscintigraphy studies to assess the feasibility of a controlled release formulation of ziprasidone

Thombre, Avinash G.; Shamblin, Sheri L.; Malhotra, Bimal; Connor, Alyson; Wilding, Ian R.; Caldwell, W. Brett

doi:10.1016/j.jconrel.2015.06.032

Cited by 16 publications

(5 citation statements)

References 53 publications

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“…Sonication period of 30 minutes was chosen since it produced the smallest mean particle size and highest saturation solubility. [42] The saturation solubility of telmisartan nanosuspension from an improved batch and pure medication were 100.18 µg/ml and 3.53 µg/ml, respectively. The dissolving profiles for the commercial formulation [Inditel 40 Tablet], unmilled [pure drug] suspension, and nanosuspension are displayed in Fig 2 . In nanosuspension, more than 102.61% of the medication was released in less than two minutes, despite the fact that the cumulative percentage of drug release from un-milled suspension and commercially manufactured suspension revealed 16.42% and 77.09% at 60 minutes, respectively.…”

Section: Telmisartan Nanosuspensionmentioning

confidence: 95%

“…The dissolving profiles for the commercial formulation [Inditel 40 Tablet], unmilled [pure drug] suspension, and nanosuspension are displayed in Fig 2 . In nanosuspension, more than 102.61% of the medication was released in less than two minutes, despite the fact that the cumulative percentage of drug release from un-milled suspension and commercially manufactured suspension revealed 16.42% and 77.09% at 60 minutes, respectively. [42][43] A range of assessment criteria, such as saturation solubility and mean particle size, were used to test the prepared nanosuspensions. Since poloxamer 407 had the highest saturation solubility and the smallest mean particle size, 50 mg of it was selected.…”

Section: Telmisartan Nanosuspensionmentioning

confidence: 99%

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Methods for Making a Nanosuspension of Poorly Soluble Medications

V.,

2023

ijnrph

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Class II prescriptions are known to dissolve ineffectively in both natural and fluid solvents, making them a significantly more challenging challenge. When it comes to these kinds of high log P synthetic compounds that are insoluble in water, the nanosuspension structure is desired. The overall bioavailability of nanosuspensions is influenced by an increase in surface area and a decrease in molecule size. Sometimes the oral dosage forms of water-soluble drugs that are slowly absorbed and inefficient show insufficient bioavailability. A drug's permeability and solubility have a significant impact on how bioavailable it is. To create sub-micron-sized particles, a suitable emulsifier and a pharmaceutical mixture are fed through a high-pressure homogenization or milling procedure. Both classic milling and precipitation processes are commonly used to create particles larger than one millimetre. In this investigation, the techniques was used to prepare the nanosuspension for improving the solubility of poorly soluble drugs.

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Section: Telmisartan Nanosuspensionmentioning

confidence: 95%

Section: Telmisartan Nanosuspensionmentioning

confidence: 99%

Methods for Making a Nanosuspension of Poorly Soluble Medications

V.,

2023

ijnrph

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“…Enterion™ kapsle je hojně využívána v klinických studiích pro stanovení biologické dostupnosti léčiv a pro validaci vývojových strategií v terapii chorob CNS, např. schizofrenie, gastrointestinálních a metabolických onemocněních 12 .…”

Section: Kapsle Enterion Tmunclassified

Delivery Systems with an Electronic Element

Koutná,

Vysloužil,

Kubová

2024

Chem. Listy

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Delivery systems with an electronic element can be classified as one of the last few decades' most modern and innovative pharmaceutical systems. Incorporating an electronic/digital element offers several advantages, such as the possibility of the precise timing of the drug released in the desired location of the gastrointestinal tract, collection of biometric data, or indisputable proof of the patient's adherence to therapy. Currently, it is possible to observe the development of the field in two main directions. The first one is using these systems in conjunction with the controlled release principle in absorption and general pharmacokinetic studies of new substances. The second direction is digital monitoring of therapy adherence. This brief overview briefly mentions the field's history, brings information about the two main branches, and states the essential systems of both branches and their use.

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“…12 This technique is also used for evaluating formulations at the preclinical and clinical stages of the development of drug delivery using novel drug carrier systems. [16][17][18][19] Calcirol ® Softgel is an oral cholecalciferol soft gelatin capsule formulation manufactured by Cadila Pharmaceuticals Ltd., Ahmedabad, India. This study was performed to evaluate the bioavailability and biodistribution pattern, transit time, and gastrointestinal clearance of a single dose of Calcirol ® soft gelatin capsule using pharmacoscintigraphy, to estimate serial plasma cholecalciferol level after its administration, and assess its safety in six healthy human volunteers.…”

Section: Introductionmentioning

confidence: 99%

Determination of the bioavailability and biodistribution of a single dose of oral cholecalciferol/Calcirol® soft gelatin capsule by pharmacoscintigraphy- CalSci study

Sahay¹,

Saresa

Changani

et al. 2023

Int J Basic Clin Pharmacol

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Background: It is required to study the bioavailability and biodistribution of specific cholecalciferol formulation before prescribing. Pharmacoscintigraphy is an established radiological-imaging technique that is used to map various drug formulations as they traverses the human body (biodistribution) in real-time. We evaluated the bioavailability and biodistribution pattern, transit time, and gastrointestinal clearance of a single dose of Calcirol® soft gelatin capsule 60,000 IU [an oral cholecalciferol (vitamin D) formulation] using pharmacoscintigraphy. Methods: Six male healthy adult volunteers were administered a single oral dose of Calcirol® soft gelatin capsule labelled with technetium-99m. Post-dosing, serial venous blood samples were collected till day 27 for the estimation of the plasma levels of 25-hydroxycholecalciferol and 1,25-dihydroxycholecalciferol levels. Different pharmacokinetic parameters were calculated. Sequential static gamma imaging was performed to evaluate the biodistribution of Calcirol® soft gelatin capsule. Descriptive statistics was used. Various pharmacokinetic parameters were calculated from the concentration-time curves. Statistical analysis was carried out using Student’s t-test. Suitable multivariate analysis was performed based on the distribution of data. All statistical analyses were performed using SAS® Software (v 9.4). Results: The overall absorption of Calcirol® soft gelatin capsule was 93.23%, which was fully from the small intestine. It led to achieving a sufficient level of 25-hydroxycholecalciferol (>60 ng/ml) within 6 hours of oral intake. The levels of plasma 25-hydroxycholecalciferol and 1,25-dihydroxycholecalciferol increased (maximum around 6 and 18 days, respectively). The small intestinal residence time was around 16 hours. No adverse event was noted. Conclusions: This was the first pharmacoscintigraphy study in the world which demonstrated the favourable bio-distribution of the Calcirol softgels supporting its role in vitamin D supplementation.

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Pharmacoscintigraphy studies to assess the feasibility of a controlled release formulation of ziprasidone

Cited by 16 publications

References 53 publications

Methods for Making a Nanosuspension of Poorly Soluble Medications

Methods for Making a Nanosuspension of Poorly Soluble Medications

Delivery Systems with an Electronic Element

Determination of the bioavailability and biodistribution of a single dose of oral cholecalciferol/Calcirol® soft gelatin capsule by pharmacoscintigraphy- CalSci study

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