Behavior Of Tablets Research Articles

A Research on: Formulation and Evaluation of Sustained Release matrix Tablets

The study focused on developing a sustained release matrix tablet of Mosapride Citrate to achieve prolonged therapeutic effects, reduce side effects, and improve patient compliance by minimizing dosing frequency. Mosapride Citrate, with a half-life of 2-3 hours, was used as a model drug. Matrix tablets were prepared using different viscosity grades of Eudragit through direct compression and evaluated. Results indicated that polymer matrices alone were insufficient for 8-hour sustained release, whereas a combination of Eudragit RS 100, Eudragit RL 100, and Eudragit E 100 provided effective sustained release, primarily through diffusion. The study also aimed to identify and rectify manufacturing defects. Mosapride Citrate tablets displayed good dissolution and tableting behavior. Preformulation studies evaluated physical properties like bulk and tapped density, angle of repose, compressibility, and Housner’s ratio. Tablet formulations underwent evaluations for thickness, hardness, friability, weight variation, assay, dissolution, and stability, with optimized formulations compared to marketed samples.

Unveiling Swelling and Erosion Dynamics: Early Development Screening of Mirabegron Extended Release Tablets

Although the development of extended release (ER) matrices has been extensively investigated, understanding the most appropriate mechanism of drug release to achieve the desired release remains a cost- and time-consuming challenge in the early stages of formulation development. This study aimed to investigate the early stage of developing ER hydrophilic matrix tablets containing mirabegron as a model drug, focusing on the effects of polymer type, diluent type, and polymer amount on critical quality attributes (CQAs), namely, tablet swelling and erosion behavior. A full factorial design was employed to explore the interactions of control factors through multivariate regression analysis, emphasizing the application of quality by design (QbD) principles. The swelling and erosion performances of 72 formulations were evaluated. The swelling data were fitted to the Vergnaud model. Finally, in vitro drug release profiles were investigated for four of the formulations studied. The polymer type, diluent type, and polymer amount had distinct effects on the swelling and erosion behavior of the ER matrix tablets. Compared with those with isomalt (G720) or dextrate (DXT), formulations with polyethylene glycol 8000 (P8000) consistently exhibited greater swelling. Additionally, higher molecular weight was correlated with increased swelling within the same polymer type. Hydroxypropylmethylcellulose (HPMC) and polyethylene oxide (PEO)-based formulations showed higher swelling rates, while polyvinyl alcohol (PVA-80) displayed the highest erosion percentage. The findings highlight the significance of incorporating early-stage screening designs to maximize efficiency and optimize time and resource. This approach enables the development of a comprehensive understanding of drug release mechanisms from ER matrix tablets.Graphical abstract

A Phase 1 Randomized, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enteric-Coated Stabilized Sulforaphane (SFX-01) in Male Participants.

Sulforaphane (SFN) is a naturally occurring isothiocyanate associated with various health benefits, including reduced cancer risk, and has been extensively explored as a potential therapeutic. However, its inherent instability presents challenges in formulation, storage, and administration as a medicinal product. SFX-01 (Sulforadex®) is a patented synthetic form of d,l-SFN stabilized within a biologically inert alpha-cyclodextrin complex. The safety, tolerability, and pharmacokinetics of an enteric-coated tablet formulation of SFX-01 were evaluated in a randomized, double-blind, placebo-controlled, dose-escalation study [300mg once daily (46.2mg SFN), 300mg twice daily or 600mg once daily (92.4mg SFN)] over 7days in healthy male participants. Treatment-emergent adverse events (TEAEs) occurred in 94% of participants who received SFX-01 and were most commonly gastrointestinal events, which were mild in severity and related to treatment. Following ingestion of SFX-01 tablets, SFN was rapidly absorbed, with a timescale consistent with the enteric coating, and subsequently metabolized. The observed peak blood concentration (Cmax) for the sum of SFN and metabolites (total thiol) across all treatment cohorts ranged from 0.43 to 2.12µmol/L in 3-6h. Cmax data were considered inconclusive with respect to dose-proportionality and there was minimal evidence of accumulation of SFN and metabolites. Urinary excretion of SFN and individual metabolites ranged from<1 to 41%, and the proportion excreted did not appear to be influenced by the dose. This study demonstrated the safety and tolerability of SFX-01 over 7days and indicated that the pharmacokinetic behavior of SFX-01 enteric-coated tablets was in line with expectations. European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) number: 2022-001601-43; ISRCTN Study Registration number: ISRCTN9628565.

Relaxation tests for the time dependent behavior of pharmaceutical tablets: A revised interpretation

Relaxation tests are often used in the pharmaceutical field to assess the strain rate sensitivity of pharmaceutical powders and tablets. These tests involve applying a constant strain to the powder in the die and then monitoring the stress evolution over time. Interpreting these tests is complicated because different physical phenomena, mainly viscoelasticity and viscoplasticity, occur simultaneously. These two phenomena cannot be distinguished by observing the evolution of the axial pressure alone, as it decreases in both cases. In this work, it was shown that monitoring the evolution of the die-wall pressure during relaxation can help separate the effects of these phenomena. Theoretical considerations revealed that during viscoplasticity, the die-wall pressure also decreases, whereas an increase in the die-wall pressure during relaxation indicates a viscoelastic relaxation. This was confirmed experimentally using specially designed compaction cycles on four different pharmaceutical excipients. Experimental results indicated that at low pressure, viscoplasticity was predominant, whereas at high pressure, viscoelasticity became more prominent. These results suggest that at low pressures, relaxation tests can be used to assess the viscoplastic properties of different products. However, the use of high pressure should always be avoided as viscoelastic phenomena might become more significant, and the combination of both phenomena might compromise the interpretation.

Using the Theory of Planned Behavior to Explore Factors Associated with the Behavior of Consuming Blood Booster Tablets Among Adolescent Girls in Bantul Regency

Background: Providing iron and folic acid through the ingestion of blood booster tablets is an intervention to lower the prevalence of anemia in adolescents. However, just a small percentage of adolescent girls have consumed blood booster tablets as prescribed. Aims: To identify the factors related to the behavior of consuming blood booster tablets among adolescent girls in Bantul Regency based on the Theory of Planned Behavior. Methods: The cross-sectional study was conducted in Bantul Regency, a Special Region of Yogyakarta Province, between March and May 2023. A total of 381 adolescent girls aged 16-18 years participated in filling out questionnaires to collect data. The questionnaire includes socio-demographics, knowledge about blood booster tablets and anemia, attitudes, subjective norms, intentions, and behaviors of consuming blood booster tablets. Path Analysis was used to analyze the data with statistical significance (p) at 0.05. Result: As a result, intention directly influences the behavior of consuming blood booster tablets (p=˂0.001). Subjective norms have a direct influence on the behavior of consuming blood booster tablets (p=0.023) and have an indirect influence through attitudes (p˂0.001) and intentions (p˂0.001). Attitude has an indirect influence on the behavior of consuming blood booster tablets through intention (˂0.001), then the level of knowledge has an indirect influence on intention (p=0.037) and attitude (p=0.032). Conclusion: Adolescent girls will have good consumption behavior of blood booster tablets if they have a positive attitude, a high level of knowledge, subjective norms, and high intentions. These findings can be used to design health promotion models useful for increasing the consumption behavior of blood booster tablets. Further research is needed to find the right educational model to increase knowledge, attitudes, subjective norms, and intentions to consume blood booster tablets.

From Field to Pharmacy: Isolation, Characterization and Tableting Behaviour of Microcrystalline Cellulose from Wheat and Corn Harvest Residues.

A lack of strategies for the utilization of harvest residues (HRs) has led to serious environmental problems due to an accumulation of these residues or their burning in the field. In this study, wheat and corn HRs were used as feedstock for the production of microcrystalline cellulose (MCC) by treatment with 2-8% sodium hydroxide, 10% hydrogen peroxide and further hydrolysis with 1-2 M hydrochloric acid. The changes in the FT-IR spectra and PXRD diffractograms after chemical treatment confirmed the removal of most of the lignin, hemicellulose and amorphous fraction of cellulose. A higher degree of crystallinity was observed for MCC obtained from corn HRs, which was attributed to a more efficient removal of lignin and hemicellulose by a higher sodium hydroxide concentration, which facilitates the dissolution of amorphous cellulose during acid hydrolysis. MCC obtained from HRs exhibited lower bulk density and poorer flow properties but similar or better tableting properties compared to commercial MCC (CeolusTM PH101). The lower ejection and detachment stress suggests that MCC isolated from HRs requires less lubricant compared to commercial MCC. This study showed that MCC isolated from wheat and corn HRs exhibits comparable tableting behaviour like commercial sample, further supporting this type of agricultural waste utilization.

Specific surface area of mannitol rather than particle size dominant the dissolution rate of poorly water-soluble drug tablets: A study of binary mixture

The dissolution behavior of tablets, particularly those containing poorly water-soluble drugs, is a critical factor in determining their absorption and therapeutic efficacy. Traditionally, the particle size of excipients has been considered a key property affecting tablet dissolution. However, lurasidone hydrochloride (LH) tablets prepared by similar particle size mannitol, namely M200 (D90 = 209.68 ± 1.42 μm) and 160C (D90 = 195.38 ± 6.87 μm), exhibiting significant differences in their dissolution behavior. In order to find the fundamental influential factors of mannitol influencing the dissolution of LH tablets, the properties (particle size, water content, true density, bulk density, tapped density, specific surface area, circularity, surface free energy, mechanical properties and flowability) of five grades mannitol including M200 and 160C were investigated. Principal component analysis (PCA) was used to establish a relationship between mannitol properties and the dissolution behavior of LH. The results demonstrated that specific surface area (SSA) emerged as the key property influencing the dissolution of LH tablets. Moreover, our investigation based on the percolation theory provided further insights that the SSA of mannitol influences the probability of LH-LH bonding and LH infinite cluster formation, resulting in the different percolation threshold states, then led to different dissolution behaviors. Importantly, it is worth noting that these findings do not invalidate previous conclusions, as reducing particle size generally increases SSA, thereby affecting the percolation threshold and dissolution behavior of LH. Instead, this study provides a deeper understanding of the underlying role played by excipient SSA in the dissolution of drug tablets. This study provides valuable guidance for the development of novel excipients aimed at improving drug dissolution functionality.

The effect of glidant on the tabletting behavior of common pharmaceutical excipients

Glidant used for the purpose of powder flowability enhancement is well known within the pharmaceutical industry to improve tablet manufacturing. Despite the widespread use of glidant for this purpose, the effect of glidant on the effect of tableting behavior is not well studied. To address this deficiency, the effect on glidant on the tabletting behavior of seven common excipients was investigated. Tabletability, compressibility, compactability, and tablet expansion were studied. It was shown that glidant increased the tabletability for excipients known to exhibit plastic behavior. Based on compressibility and compactability, it was inferred that an increase in total bonding strength due to the presence of glidant was responsible for the improvement in tabletability. Results suggest this may be due to an increase in inter-particle bonding area. Conversely, glidants did not affect the tabletability of brittle excipients. The effect of glidant on die-fill bulk density was also studied to examine the impact associated with air entrapment and tablet expansion. While glidant significantly increased the die-fill powder density, this did not have an observable effect on tablet expansion or any other tabletting behavior examined.

Development of Physiologically Based Biopharmaceutical Model (PBBM) for Felodipine Prolonged-Release Tablet as useful tool for prediction of formulation.

Physiologically Based Biopharmaceutical Models (PBBMs) are advanced tools that integrate physiological parameters with drug-specific properties to simulate drug behavior in vivo. In this study, we present the development of a PBBM specifically tailored for felodipine prolonged-release (PR) tablet formulations. Felodipine, a potent calcium channel blocker, is widely used for the treatment of hypertension and angina pectoris. Prolonged-release formulations aim to provide controlled drug release, ensuring sustained therapeutic effect with reduced dosing frequency and minimized adverse effects. Our PBBM incorporates key physiological processes such as gastrointestinal transit, drug dissolution, absorption, distribution, metabolism, and elimination. Data from in vitro dissolution studies, preclinical pharmacokinetics, and clinical observations are integrated to parameterize the model accurately. Special attention is given to the physicochemical properties of felodipine and the release characteristics of the PR tablet formulation. Validation of the PBBM is conducted against clinical pharmacokinetic data obtained from bioequivalence studies and population pharmacokinetic analyses of felodipine PR tablets. The model may demonstrate excellent predictive performance, accurately capturing plasma concentration-time profiles across different dosing regimens and patient populations. The developed PBBM provides valuable insights into the biopharmaceutical behavior of felodipine PR tablets, facilitating rational formulation design, dosage regimen optimization, and therapeutic individualization. It serves as a powerful tool for drug developers, regulatory agencies, and clinicians to enhance the efficiency and effectiveness of drug development and clinical pharmacotherapy

Tableting behavior of freeze and spray-dried excipients in pharmaceutical formulations

Most of biopharmaceuticals, in their liquid form, are prone to instabilities during storage. In order to improve their stability, lyophilization is the most commonly used drying technique in the pharmaceutical industry. In addition, certain applications of biopharmaceutical products can be considered by oral administration and tablets are the most frequent solid pharmaceutical dosage form used for oral route. Thus, the tableting properties of freeze-dried products used as cryo and lyoprotectant could be a key element for future pharmaceutical developments and applications. In this study, we investigated the properties that might play a particular role in the specific compaction behavior of freeze-dried excipients. The tableting properties of freeze-dried trehalose, lactose and mannitol were investigated and compared to other forms of these excipients (spray-dried, commercial crystalline and commercial crystalline milled powders). The obtained results showed a specific behavior in terms of compressibility, tabletability and brittleness for the amorphous powders obtained after freeze-drying. The comparison with the other powders showed that this specific tableting behavior is linked to both the specific texture and the physical state (amorphization) of these freeze-dried powders.

The impact of diluents on the compaction, dissolution, and physical stability of amorphous solid dispersion tablets

Amorphous solid dispersion (ASD) is an effective approach for enhancing the solubility, dissolution, and bioavailability of poorly water-soluble drugs. However, these metastable forms can transform into more thermodynamically stable but less soluble crystalline forms. Despite this challenge, research on processing ASDs into solid dosage forms, such as tablets, is lacking. This work aims to fill this gap by investigating the impact of common diluents on the tableting behavior, dissolution, and physical stability of ASDs composed of itraconazole and hypromellose acetate succinate. Four widely used diluents found in commercially available ASD tablets were selected for the study: microcrystalline cellulose (MCC), anhydrous lactose, starch, and mannitol. The performance of ASD tablets varied significantly depending on the diluent used. Tablets prepared with MCC exhibited higher mechanical strength than those formulated using other diluents. ASD tablets containing mannitol and lactose revealed a faster release rate than those composed of MCC or starch. Notably, the study highlighted that the physical stability of ASDs within a tablet is not solely dependent on the amount of sorbed water; crystalline diluents like lactose and mannitol were found to facilitate ASD recrystallization within a tablet. In summary, the study underscores the importance of excipient selection, considering factors such as mechanical strength, dissolution rate, and physical stability of ASD tablets. These findings offer valuable insights into the selection of excipients for downstream ASD tablet development, leading to improved manufacturability, physical stability, and the overall quality of ASD drug products.

Structural and functional analysis of a new co-processed tableting excipient for food compaction processes

Food compacts are convenient to industry and customers and must primarily possess a sufficient strength to withstand packaging processing and customer handling. In contrast to pharmaceutical applications, the choice of excipients is usually limited to necessary ingredients of the final food product. In accordance, novel, better performing materials derived from advanced processing of common food constituents are highly attractive. This study thoroughly characterizes the properties of such a novel, co-processed food material called “Salt-Starch” to demonstrate its superior tableting behavior and to investigate the cause of its superiority. For a fundamental understanding of the binding mechanisms and the resulting structure, tabletability, compressibility, compactibility and elastic recovery of compacts based on Salt-Starch, its sole starting components with different particle sizes and their physical blends are investigated. Results indicate, that the specific structure of a viscoelastic continuous phase of starch and a brittle-ductile dispersed phase of (sub-)micron-sized sodium chloride lead to superior strength of Salt-Starch, which cannot be achieved by physical mixtures. Compacts tensile strength is elevated 40 times at an applied pressure of 55 MPa and elastic recovery is less than half compared to the elastic recovery of binary mixture tablets.

Dissolution Method for Estimation of Deflazacort in Tablet Dosage Form by UV Visible Spectroscopy

The present study describes the development and validation of multimedia dissolution method by UV- Visible Spectroscopy to evaluate the dissolution behavior of deflazacort tablets. The different dissolution media selected for this study are water, 0.1N HCl, pH 4.5 acetate buffer and pH 6.8 phosphate buffer. Spectra of deflazacort in different dissolution media were recorded in range of 200-400nm and 247nm selected as maximum absorptive point. Stability and solubility of deflazacort in different dissolution media i.e., water,0.1 N HCL, pH 4.5 acetate buffer, pH 6.8 phosphate buffer were also studied. Based on this, dissolution medium containing 0.1 N HCL, water and pH 4.5 acetate buffer were found suitable to ensure chemical stability of the deflazacort. The established dissolution conditions were 1000ml dissolution medium, apparatus USP II (paddle), agitation speed 50 RPM for 75 minutes and it is corresponding to&gt;90 % drug release within 60min. The method was validated according to ICH guideline that include accuracy, precision, specificity/selectivity and linearity. Hence, it could be concluded that the developed method can be used as dissolution method for estimation of release of deflazacort in tablet dosage form.

Effect of tableting temperature on tablet properties and dissolution behavior of heat sensitive formulations

The tableting process involves the conversion of mechanical to thermal energy. This study evaluated the influence of temperature on the tableting behavior of formulations with different compositions. The tableting machine was equipped with a thermally controlled die to mimic the heat evolution from tableting on an industrial scale. Six formulations containing binders with a comparably low glass transition temperature were examined. Besides the polymer type and concentration, the filler was varied. Paracetamol was chosen as the model active pharmaceutical ingredient. The investigation included alterations in tabletability, disintegration and dissolution. Elevated temperatures led to an enhanced tabletability. The polymer type and concentration were decisive for the extent of alterations. The variation of the filler composition played a minor role due to the high melting points of its components. The results were confirmed in disintegration and dissolution studies. A high binding capacity and a low glass transition temperature resulted in a stronger delay of disintegration. The dissolution was sustained. Increased concentrations of the binding polymer enhanced the effect. If the tableting behavior of a formulation is changed by elevated temperatures during formulation development and production, a change of the binder type or concentration should be considered to ensure a reproducible tablet quality.

Investigating the heat sensitivity of frequently used excipients with varying particle sizes

During tablet manufacturing an increase in the production temperature can lead to an alteration of tablet characteristics. In the present study, the influence of the initial particle size on the tableting behavior of ductile polymers upon temperature rise was investigated. Different grades of the respective materials were tableted at temperatures ranging from 22 to 70 °C.Alterations in tableting behavior were affected by the initial particle size. Smaller particle sizes led to a more pronounced decrease in yield pressure and net work of compaction during compressibility analysis. The results were confirmed in the tabletability studies. Tablets from binary mixtures with lactose containing smaller polymer particles yielded a stronger increase in tensile strength. Differences in the tensile strength increase of two grades from the same material correlated with the ratio of their median particle sizes. The alteration of compactibility profiles was also particle size dependent. The increase in solid fraction was more prominent for binary mixtures containing polymers with smaller particle sizes. However, the ratio of the median particle sizes of the compared grades showed no systematic effect.The results underline the importance of controlling the structural properties of a material carefully during formulation development and production. If a formulation responds to temperature variations, an increase in particle size might be beneficial to decrease its heat sensitivity.

Effect of geometrical features on the capping behavior of biconvex tablets

Capping is a common industrial issue during the manufacturing of pharmaceutical tablets. It is influenced by both process and formulation parameters. In this work, a systematic study of the influence of the geometrical features of biconvex tablets on capping occurrence was performed on a model formulation, using a design of experiment. Capping was characterized by the pressure at which half of the produced tablets were capped. The influence of the tablet geometry was assessed by varying three parameters: the diameter (D), the band thickness (W) and the ratio between the radius of curvature (R) and the diameter, i.e. R/D. Results showed that having a large diameter, a low band thickness and a high curvature (i.e. a low R/D) favored capping occurrence. Moreover, the effects are not independent as cross-effect were detected. Finally, even for homothetic tablets (i.e. same R/D and W/D) it is shown that a large diameter increases capping occurrence. These results could be used in the future as a guideline for punch selection during tablet development.

Prediction of dissolution performance of uncoated solid oral dosage forms via optical coherence tomography

Real-time prediction of the dissolution behavior of solid oral dosage forms is an important research topic. Although methods such as Terahertz and Raman can provide measurements that can be linked to the dissolution performance, they typically require a longer time off-line for analysis. In this paper, we present a novel strategy for analyzing uncoated compressed tablets by means of optical coherence tomography (OCT). Using OCT, which is fast and in-line capable, makes it possible to predict the dissolution behavior of tablets based on images. In our study, OCT images were obtained of individual tablets from differently produced batches. Differences between tablets or batches in these images were hardly visible to the human eye. Advanced image analysis metrics were developed to quantify the light scattering behavior captured by the OCT probe and depicted in the OCT images. Detailed investigations assured the repeatability and robustness of the measurements. A correlation between these measurements and the dissolution behavior was established. A tree-based machine learning model was used to predict the amount of dissolved active pharmaceutical ingredient (API) at certain time points for each immediate-release tablet. Our results indicate that OCT, which is a non-destructive and real-time technology, can be used for in-line monitoring of tableting processes.

Continuous Monitoring of the Hydration Behavior of Hydrophilic Matrix Tablets Using Time-Domain NMR.

Time-domain NMR (TD-NMR) was used for continuous monitoring of the hydration behavior of hydrophilic matrix tablets. The model matrix tablets comprised high molecular weight polyethylene oxide (PEO), hydroxypropyl methylcellulose (HPMC), and polyethylene glycol (PEG). The model tablets were immersed in water. Their T2 relaxation curves were acquired by TD-NMR with solid-echo sequence. A curve-fitting analysis was conducted on the acquired T2 relaxation curves to identify the NMR signals corresponding to the nongelated core remaining in the samples. The amount of nongelated core was estimated from the NMR signal intensity. The estimated values were consistent with the experiment measurement values. Next, the model tablets immersed in water were monitored continuously using TD-NMR. The difference in hydration behaviors of the HPMC and PEO matrix tablets was then characterized fully. The nongelated core of the HPMC matrix tablets disappeared more slowly than that of the PEO matrix tablets. The behavior of HPMC was significantly affected by the PEG content in the tablets. It is suggested that the TD-NMR method has potential to be utilized to evaluate the gel layer properties, upon replacement of the immersion medium: purified (nondeuterated) water is replaced with heavy (deuterated) water. Finally, drug-containing matrix tablets were tested. Diltiazem hydrochloride (a highly water-soluble drug) was employed for this experiment. Reasonable in vitro drug dissolution profiles, which were in accordance with the results from TD-NMR experiments, were observed. We concluded that TD-NMR is a powerful tool to evaluate the hydration properties of hydrophilic matrix tablets.

Behavioral Factor Analysis of Blood Supplement Tablet Consumption in Adolescent Girls as an Effort to Prevent Stunting

The provision of blood supplement tablets (TTD) for adolescent girls is one of the special interventions being pursued by the government to improve the compliance of adolescent girls in taking blood supplement tablets. The government collaborates with health services and educational institutions in distributing TTD. SMP Negeri 2 Bumi Ratu Nuban is a pilot school in the working area of Puskesmas Inpatient Wates. However, the lack of awareness and support provided makes adolescent girls irregular in consuming TTD. The purpose of this study was to analyze the behavioral factors of blood supplement tablets consumption in adolescent girls in an effort to prevent stunting. This type of analytical observational research with a cross sectional design, the population of all adolescent girls. sampling using total sampling with the number of respondents 117 adolescent girls who have menstruated at SMPN 2 Bumi Ratu Nuban. Data collection using a questionnaire. Data analysis using the Chi-Square test. Based on the results of the chi-square test there is a relationship between knowledge (P-Value= 0.002; OR= 7.5; 95%; CL= 1.93-29), attitude (P-Value= 0.039; OR= 2.42, I= 1.116-5. 252), health worker support (P-Value = 0.003; OR = 3.68; 95%; CI = 1.62-8.36) and parental support (P-Value= 0.000; OR= 8.2; 95%; CI= 3.44-19.6) with the consumption behavior of blood supplement tablets in adolescent girls. It is expected that educational activities and monitoring of my health report card book are carried out continuously by health workers who can involve teachers and parents directly.

Evaluation of the Effect of Disintegrant Distribution on the Dissolution Behavior of Pharmaceutical Tablets Using Raman Chemical Imaging.

In pharmaceutics, substandard drug manufacturing can sometimes occur. Usually, end-product release tests are conducted to detect defective products, but in many cases, they are not able to identify the root causes of quality defects. In recent years, chemical imaging techniques have been widely used to study quality defects by visualizing the distribution of components in solid dosage forms. However, in most studies, the causes are predicted from images of ingredients, and the impact of each factor is unclear. In this study, we prepared model tablets and intentionally changed only the distribution of disintegrants, and visualized this distribution using the Raman chemical imaging technique to evaluate the effect on the dissolution behavior of the tablets. We found that tablet disintegration occurs completely when the amount of disintegrant is sufficient to disintegrate the tablet and is distributed throughout the tablet, even if the distribution is not uniform. In contrast, if there was a large area where the disintegrant was not present, the tablet did not disintegrate sufficiently. This suggests that it is more important that a sufficient amount of disintegrant is present throughout the tablet rather than the degree of deviation of disintegrant distribution.