Quality by Design Applied Development of Immediate-Release Rabeprazole Sodium Dry-Coated Tablet

Lee, Sang-Ho; Kim, Joo-Eun

doi:10.3390/pharmaceutics13020259

Cited by 17 publications

(16 citation statements)

References 38 publications

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“…The initial risk assessment was based on prior knowledge, screening experiments, and experience and information about pharmaceutical dosage form, obtained from published literature. In the PHA, the material attribute (MA) and process parameter (PP), obtained through preliminary studies, were listed [10,19]. CMA has a critical effect on CQA among various material attributes.…”

Section: Initial Risk Assessment By Preliminary Hazard Analysismentioning

confidence: 99%

“…As shown in Figure 1, the results of an FMEA are risk priority numbers (RPN) for each combination of failure mode severity, probability, and likelihood of detection [10]. The RPN defined as the overall failure risk, was evaluated based on three criteria: frequency of probability (P), effect severity (S), and detect ability (D) each of them rated on a scale from 1, as the low level of the mentioned criteria to 4, as the high level of the criteria [19]. The final values (RPN) were confirmed by the multiplication of the values registered for each of the three items [20].…”

Section: Main Risk Assessment By Failure Mode and Effect Analysismentioning

confidence: 99%

“…We evaluated the main, interaction, and quadratic effects of factors related to the properties of monolayered TA tablets and investigated the effect of each independent variable on the dependent variable. Variables with p-values less than 0.05 were regarded as statistically significant [19].…”

Section: Design Of Experimentsmentioning

confidence: 99%

“…To increase the patient's compliance by reducing the size of the tablet by half and to overcome various problems that occur during when manufacturing a single-layered tablet that has been developed from a double-layered tablet, our research team developed a single-layered tablet by applying a risk assessment (RA) using the QbD approach [19].…”

Section: Introductionmentioning

confidence: 99%

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QbD Consideration for Developing a Double-Layered Tablet into a Single-Layered Tablet with Telmisartan and Amlodipine

Kim

Park

2022

Pharmaceutics

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The aim of this study was to develop a single-layered version of commercially available Twynstar® (Telmisartan + Amlodipine) double-layered tablets to improve the dosing convenience. A quality-by-design approach was applied to develop the single-layered version. To evaluate the range and cause of risks for a single-layered tablet in the formulation design research, we used the tools of the risk assessment, initial risk assessment of preliminary hazard analysis and main risk assessment of failure mode and effect analysis to determine the parameters affecting formulation, drug dissolution, and impurities. The critical material attributes were the stabilizer and disintegrant, and the critical process parameters were the wet granulation and tableting process. The optimal range of the design space was determined using the central composite design in the wet granulation and tablet compression processes. The stabilizer, kneading time, and disintegrant of the wet granulation were identified as X values affecting Y values. The compression force and turret speed in the tablet compression were identified as X values affecting Y values. After deciding on the design space with the deduced Y values, the single-layered tablets were formulated, and their dissolution patterns were compared with that of the double-layered tablet. The selected quality-by-design (QbD) approach single-layered tablet formulated using design space were found to be bioequivalent to the Twynstar® double-layered tablets. Hence, the development of single-layered tablets with two API using the QbD approach could improve the medication compliance of patients and could be used as a platform to overcome time-consuming and excessive costs and the technical and commercial limitations related to various multi-layered tablets.

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Section: Initial Risk Assessment By Preliminary Hazard Analysismentioning

confidence: 99%

Section: Main Risk Assessment By Failure Mode and Effect Analysismentioning

confidence: 99%

Section: Design Of Experimentsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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QbD Consideration for Developing a Double-Layered Tablet into a Single-Layered Tablet with Telmisartan and Amlodipine

Kim

Park

2022

Pharmaceutics

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“…Then, the tablets were reweighed and noted as W2. The weight difference in percentage [(W1 − W2)•100/W1] was noted and expressed as a percentage [20].…”

Section: Hardness and Friabilitymentioning

confidence: 99%

Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate

et al. 2021

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The development of new drugs that combine active ingredients for the treatment hypertension is critically essential owing to its offering advantages for both patients and manufacturers. In this study, for the first time, detailed development of a scalable process of film-coated bi-layer tablets containing sustained-release metoprolol succinate and immediate-release amlodipine besylate in a batch size of 10,000 tablets is reported. The processing parameters of the manufacturing process during dry mixing-, drying-, dry mixing- completion stages were systematically investigated, and the evaluation of the film-coated bi-layer tablet properties was well established. The optimal preparation conditions for metoprolol succinate layer were 6 min- dry mixing with a high-speed mixer (120 rpm and 1400 rpm), 30-min drying with a fluid bed dryer, and 5-min- mixing completion at 25 rpm. For the preparation of amlodipine besylate layer, the optimal dry-mixing time using a cube mixer (25 rpm) was found to be 5 min. The average weight of metoprolol succinate layers and bi-layer tablets were controlled at 240–260 mg and 384–416 mg, respectively. Shewhart R chart and X¯ charts of all three sampling lots were satisfactory, confirming that the present scalable process was stable and successful. This study confirms that the manufacturing process is reproducible, robust; and it yields a consistent product that meets specifications.

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Pharmacokinetics and Pharmacodynamics of Lansoprazole/Sodium Bicarbonate Immediate‐release Capsules in Healthy Chinese Subjects: An Open, Randomized, Controlled, Crossover, Single‐, and Multiple‐dose Trial

Li-xiu

Zhai

et al. 2023

Clinical Pharm in Drug Dev

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Proton pump inhibitors (PPIs) differ in onset of action and bioavailability. This trial was conducted to investigate the pharmacokinetics and pharmacodynamics of an immediate‐release capsule formulation containing lansoprazole 30 mg and sodium bicarbonate 1100 mg (T preparation) in healthy Chinese subjects. This was an open, single‐center, randomized, single and multiple oral doses, and two‐period crossover study in 30 healthy subjects. After single‐ and multiple‐dose oral administration, blood samples were obtained and lansoprazole concentration in serum was measured for pharmacokinetic analysis. Meanwhile, the intragastric pH was monitored continuously to evaluate the pharmacodynamics of the investigational drugs. The Tmax of the T preparation was 0.5 hours, while the Tmax of the R preparation was 1.5 hours after multiple doses, which indicated that the absorption speed of the T preparation was significantly faster than that of the R preparation. The same characteristics also existed after single‐dose administration. The area under the curve (AUC)ss of the T preparation was bio‐equivalent to that of the R preparation under steady state. The time percentage of intragastric pH > 4.0 for the T preparation was higher than that of the R preparation after 1 hour for both single‐ and multiple‐dose. It suggested compared with R preparation, the time percentage of intragastric pH > 4.0 met the criteria for superiority after 1 hour administration for the T preparation. In addition, no serious adverse events occurred in this study. Across this study, the T preparation was better than the R preparation at improving drug absorption and increasing intragastric pH, and had a favorable safety profile.

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Quality by Design Applied Development of Immediate-Release Rabeprazole Sodium Dry-Coated Tablet

Cited by 17 publications

References 38 publications

QbD Consideration for Developing a Double-Layered Tablet into a Single-Layered Tablet with Telmisartan and Amlodipine

QbD Consideration for Developing a Double-Layered Tablet into a Single-Layered Tablet with Telmisartan and Amlodipine

Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate

Pharmacokinetics and Pharmacodynamics of Lansoprazole/Sodium Bicarbonate Immediate‐release Capsules in Healthy Chinese Subjects: An Open, Randomized, Controlled, Crossover, Single‐, and Multiple‐dose Trial

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