Quantifying the effect of glidant on the compaction and tableting properties of paracetamol granules

Apeji, Yonni Eshovo; Olowosulu, Adeniji Kehinde

doi:10.35333/jrp.2020.112

Cited by 3 publications

(3 citation statements)

References 30 publications

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“…Studies reported colloidal silicon dioxide (Aerosil®), acts both as a glidant and lubricant and also helps inappreciably decreasing tablet friability by restoring the binding properties of the excipients. [21] The hardness of the LS2 liquisolid tablets was reported to be 5.78 ± 0.018 kg/cm 2 which met the criteria as displayed in the I.P between 5 kg/cm 2 and 6 kg/cm 2 , the data reveal that the LS2 tablet is having good mechanical strength. Sufficient hardness of tablet may be due to the presence of hydrogen bond between the drug and the Avicel PH102 that contribute to strength and cohesiveness among the particles.…”

Section: Post-compression Studiesmentioning

confidence: 74%

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Biju¹

2021

AJP

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Introduction: Clomiphene citrate is a nonsteroidal ovulation inducer used in the treatment of infertility. This drug belongs to biopharmaceutical classification system Class-II often possesses challenges concerning solubility or poor dissolution, drug release, and thereby enhance the bioavailability. Aim: The aim of the study was to improve the solubility of the drug as well as to make the formulation more feasible liquisolid technique was adopted. Materials and Methods: Here, Avicel PH 102(Q) and Aerosil 200(q) in varying ratios ranging from 5, 10, 20, and 25 were employed as coating and carrier materials (R=Q/q), and their quantities incorporated into formulation were calculated based on the mathematical formulae developed by Spireas and final powder substrate developed was compressed into a tablet by direct compression method. Twelve formulations LS1 to LS12 were prepared and subjected to drug excipient interactions studies, pre-compression, and post-compression studies and compared with the marketed formulation. Results and Discussion: The Fourier transform infrared spectroscopy results showed no interaction between drug-excipients. Scanning electron microscopy and X-ray diffractometry analysis indicated that the clomiphene citrate is held within the powder substrate in a solubilized, almost molecularly dispersed state and in liquisolid as an amorphous powder with no signs of instability on storage. An optimized formulation was selected based on the in vitro, drug release studies. LS2 formulation containing Avicel PH 102(Q):Aerosil 200(q) a ratio of 10:1 and drug concentration 10% exhibited the controlled and complete/highest drug release rate of 96.46% in 30 min in comparison with the marketed product. Conclusion: Thus, we propose that liquisolid technique can be chosen as the most economical and alternative approach to enhance the solubility of clomiphene citrate.

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Section: Post-compression Studiesmentioning

confidence: 74%

Untitled

Biju¹

2021

AJP

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“…The role of the glidant as an extragranular excipient is to improve the flowability of the granules (Apeji, Olowosulu, 2020). They are often added to a granulation before compression into tablets to ensure that the granules flow sufficiently from the hopper during high-speed production.…”

Section: Optimization Of the Extragranular Excipient Composition Of P...mentioning

confidence: 99%

Optimization of the Extragranular Excipient Composition of Paracetamol Tablet formulation using the Quality by Design Approach

Apeji

Ariko

Olayemi

et al. 2022

Braz. J. Pharm. Sci.

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The purpose of this study is to optimize the composition of extragranular excipients (EGE) and mixing time of granules with EGE of paracetamol tablet formulation using Design of Experiments (DoE) approach. The effect of the composition of EGE and the mixing time of granules with EGE on granule and tableting properties of paracetamol tablet formulation was investigated using a combined model of mixture and process factors (Design-Expert 12). A total of 18 tablet formulations were manufactured by wet granulation using varying compositions of EGE and varying mixing time. Granule and tablet properties of each formulation were evaluated as response variables for the design, data generated were fitted into models and analysed to generate a design space that was used for optimization studies. The proposed EGE composition as predicted by the design was confirmed and validated after preparation and evaluation of the granule and tablet properties. The optimized composition for the EGE that yielded granules and tablets of desirable characteristics was found to be maize starch (5 %), talc (4.9 %) and magnesium stearate (0.1 %) with a mixing time of 2 min. The tablets produced with the optimized composition had better mechanical strength and disintegration time than the formulation prepared using an existing formula of maize starch (7.8 %), talc (2 %) and magnesium stearate (0.2 %) that were obtained using the One Variable at a Time (OVAT) approach. This study confirmed the relevance of quality by design in development of pharmaceutical formulations.

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“…Monitoring and control of CQAs such as tensile strength and tablet porosity are critical as they are linked to dissolution profiles of the manufactured tablets, which are ultimately linked to patient safety and treatment efficacy [12][13][14][15][16]. Tablet tensile strength and dissolution profile are affected by various factors such as particle size, API concentration, and addition of lubricants and glidant [17,18]. Glidants are added to improve the flowability of the blend.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of a Combined MHE-NMPC Approach to Handle Plant-Model Mismatch in a Rotary Tablet Press

et al. 2021

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The transition from batch to continuous processes in the pharmaceutical industry has been driven by the potential improvement in process controllability, product quality homogeneity, and reduction of material inventory. A quality-by-control (QbC) approach has been implemented in a variety of pharmaceutical product manufacturing modalities to increase product quality through a three-level hierarchical control structure. In the implementation of the QbC approach it is common practice to simplify control algorithms by utilizing linearized models with constant model parameters. Nonlinear model predictive control (NMPC) can effectively deliver control functionality for highly sensitive variations and nonlinear multiple-input-multiple-output (MIMO) systems, which is essential for the highly regulated pharmaceutical manufacturing industry. This work focuses on developing and implementing NMPC in continuous manufacturing of solid dosage forms. To mitigate control degradation caused by plant-model mismatch, careful monitoring and continuous improvement strategies are studied. When moving horizon estimation (MHE) is integrated with NMPC, historical data in the past time window together with real-time data from the sensor network enable state estimation and accurate tracking of the highly sensitive model parameters. The adaptive model used in the NMPC strategy can compensate for process uncertainties, further reducing plant-model mismatch effects. The nonlinear mechanistic model used in both MHE and NMPC can predict the essential but complex powder properties and provide physical interpretation of abnormal events. The adaptive NMPC implementation and its real-time control performance analysis and practical applicability are demonstrated through a series of illustrative examples that highlight the effectiveness of the proposed approach for different scenarios of plant-model mismatch, while also incorporating glidant effects.

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Quantifying the effect of glidant on the compaction and tableting properties of paracetamol granules

Cited by 3 publications

References 30 publications

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Optimization of the Extragranular Excipient Composition of Paracetamol Tablet formulation using the Quality by Design Approach

Evaluation of a Combined MHE-NMPC Approach to Handle Plant-Model Mismatch in a Rotary Tablet Press

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