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DESU® MCC Selection Analysis Based on Different Drying Processes 1. Introduction Microcrystalline cellulose (MCC)—a pharmaceutical-grade, NF/USP/EP/JP-compliant excipient—is one of the most commonly used ingredients in oral solid dosage forms, and its production process has significant impact on product quality. Currently, two main drying processes are used industrially for MCC production: Spray Drying and Flash Drying. Spray drying process atomizes MCC slurry and rapidly dries it in hot air flow, obtaining spherical or quasi-spherical particles; flash drying process combines mechanical pulverization with air flow drying, obtaining fibrous particles. Both processes have their own characteristics and are suitable for different formulation scenarios. Modern Chinese MCC production has advanced considerably: spray-dried products offer good flowability, uniform particle size, and high batch-to-batch consistency, while flash-dried products compact better under specific conditions. As a spray-dried technology supplier, Westpoint's DESU® helps formulation companies understand products from different processes and choose accordingly. This study analyzes the performance differences between DESU® Microcrystalline cellulose (spray-dried process) and Chinese Brand (flash-dried process) in physicochemical indicators, powder characteristics, and formulation applications through systematic performance comparison studies, discusses the application scenarios of the two processes, and provides scientific basis for MCC selection by formulation companies. 2. Experimental Methods 2.1 Physicochemical Indicators and Powder Characterization Testing According to Chinese Pharmacopeia 2025 Edition Part IV General Rules, pH value, degree of polymerization, loss on drying, residue on ignition, bulk density, and particle size distribution were determined. Powder comprehensive characteristics tester was used to measure bulk density, tapped density, and angle of repose, and Carr's index and Hausner ratio were calculated. 2.2 Direct Compression Performance Evaluation Different MCC sources were mixed with 1% magnesium stearate and directly compressed at four pressure gradients: 3.0, 5.0, 8.0, and 12.0 kN. Tablet weight variation, hardness, friability, and disintegration time were measured. 2.3 Model Formulation Application Study Amlodipine besylate tablets (direct compression process) were selected as model formulations to compare the application performance of different sources of MCC in typical formulations. 3. Results and Discussion 3.1 Product Characteristics Analysis of Different Drying Processes Spray Drying Process: MCC slurry is dispersed into tiny droplets by an atomizer and rapidly dried in high-temperature air flow, usually within five seconds. The process yields spherical or quasi-spherical particles with uniform thermal history, good flowability, and narrow particle size distribution. Spray-dried products perform well in high-speed compression and wet granulation, making them the mainstream choice for high-end formulations. Flash Drying Process: MCC slurry enters the drying chamber after mechanical pulverization and is dried by a high-speed rotating dispersing device with hot air flow. The process produces fibrous particles with strong mechanical action, offering better compactibility at low pressures. However, flash-dried products have poorer flowability, declining disintegration performance at high hardness, and higher bulk density, which limits their application scope. Table 1 compares the two MCC samples. DESU® Microcrystalline cellulose PH-102 (spray-dried) has a degree of polymerization of 266-278, within the ideal range; Chinese Brand (flash-dried) is 245-255, slightly lower, reflecting the stronger mechanical shear of flash drying. Table 1 Comparison of Physicochemical Indicators of MCC from Different Sources Test Item DESU® MCC PH-102 (Spray-Dried) Chinese Brand (Flash-Dried) Difference Explanation Degree of Polymerization 266-278 245-255 Flash process has stronger mechanical action Loss on Drying (%) 3.0-3.5 2.8-3.2 Both within standard range Bulk Density (g/ml) 0.31-0.33 0.35-0.38 Flash process has slightly higher bulk density D50 (μm) 100-110 95-105 Both within standard range 3.2 Powder Characteristics Comparison Table 2 shows the powder characterization data of two MCC samples. Table 2 Powder Characterization Data of MCC from Different Sources Test Item DESU® MCC PH-102  (Spray-Dried) Chinese Brand (Flash-Dried) Evaluation Standard Carr's Index (%) 22.5 25.8 <35% is good Hausner Ratio 1.29 1.35 <1.5 is good Angle of Repose (°) 35.2 38.5 <40° is good Powder characterization shows that DESU® MCC PH-102 (spray-dried) has better flowability than Chinese Brand (flash-dried). DESU® MCC PH-102 has Carr's index 22.5%, Hausner ratio 1.29, and angle of repose 35.2°, all excellent; Chinese Brand has 25.8%, 1.35, and 38.5°, meeting general requirements with relatively weaker flow. The weaker flow of flash-dried products stems from their fibrous morphology, which can offer compactibility advantages at low pressures but may cause feeding instability above 30,000 tablets per hour. By contrast, the spherical particles of spray-dried products maintain good flow across various compression speeds. In terms of bulk density, Chinese Brand (0.35-0.38 g/ml) is slightly higher than DESU® MCC PH-102 (0.31-0.33 g/ml). Higher bulk density may affect mixing uniformity in certain specific formulations, especially for low-density APIs, requiring appropriate adjustment of process parameters. 3.3 Compressibility and Disintegration Performance Comparison In direct compression (Figure 1), the two samples differed in compressibility. At low pressures (3-5 kN), Chinese Brand (flash-dried) gave slightly higher hardness due to mechanical entanglement of its fibrous particles; above 8-12 kN, the difference diminished. Figure 1 Relationship between Main Compression Pressure and Tablet Hardness The two samples differed clearly in disintegration (Figure 2). At low hardness (60-80 N) both disintegrated in 10-15 min, meeting requirements; at high hardness (>100 N), Chinese Brand took 30-45 min—exceeding the 15 min pharmacopeia limit—while DESU® Microcrystalline cellulose remained in the ideal 15-25 min range. Figure 2 Relationship between Disintegration Time and Tablet Hardness Thus flash-dried products are better suited to low-hardness formulations (<100 N), whereas spray-dried products offer stable disintegration and broader applicability across hardness levels. 3.4 Process Application Scenario Analysis Application Scenarios for Spray-Dried Process: High-speed compression—above 30,000 tablets per hour: excellent flowability ensures stable powder feeding High hardness formulations (>100 N): Stable disintegration performance, does not deteriorate with increasing hardness Wet granulation processes: Spherical particles combine well with binders Products requiring high batch-to-batch consistency: Stable process, small quality fluctuations Application Scenarios for Flash-Dried Process: Low-pressure compression, below 5 kN: fibrous particles provide better low-pressure compactibility Medium hardness formulations (60-80 N): Disintegration performance acceptable Low-speed compression with low flowability requirements: Can utilize its compactibility characteristics 3.5 Formulation Application Evaluation and Selection Recommendations In the amlodipine besylate tablet study (direct compression), both MCC samples met quality requirements at medium hardness (60-80 N). Figure 3 shows the dissolution curves. Both tablet types had similar dissolution (f2>50), with cumulative dissolution >80% at 30 minutes, meeting standards. Figure 3 Dissolution Curves of Amlodipine Besylate Tablets under Medium Hardness Conditions However, under high hardness (>100 N) the differences were significant. Figure 4 shows the dissolution curves at high hardness. Tablets prepared with DESU® MCC PH-102 showed normal dissolution, with cumulative release >80% at 30 minutes; Chinese Product (flash-dried) tablets showed markedly delayed dissolution, about 75% at 30 minutes and reaching >80% only at 45 minutes. This aligns with the disintegration data, confirming the limitations of flash-dried products at high hardness. Figure 4 Dissolution Curves of Amlodipine Besylate Tablets under High Hardness Conditions Selection Recommendations: Formulation companies should comprehensively consider formulation characteristics and process requirements when selecting MCC: (1) Scenarios where spray-dried process is preferred: High-speed compression production line Formulations requiring high hardness (>100 N) Formulations with strict requirements for disintegration speed Products requiring high batch-to-batch consistency (2) Scenarios where flash-dried process can be considered: Low-pressure compression (<5 kN) Formulations with low target hardness (60-80 N) Low-speed compression (<20,000 tablets/hour) Products with other process parameters fully validated (3) General recommendations: The spray-dried process offers superior, broader performance and is preferred for most formulation scenarios. Flash-dried products have limited applicability because their disintegration declines with hardness; specific requirements should be fully evaluated before selection. 4. Conclusion Through systematic comparison, this study analyzed the performance of DESU® Microcrystalline cellulose from spray-dried and flash-dried processes. The main conclusions are: (1) Process differences: Spray-dried products have good flowability, stable disintegration, and high batch-to-batch consistency, with broad applicability; flash-dried products compact better at low pressures but disintegrate poorly at high hardness, limiting their use. (2) Applicable scenarios: Spray-dried suits extensive scenarios—high-speed compression, high-hardness and wet granulation formulations; flash-dried is limited to low pressure, medium hardness, and low-speed compression. (3) Selection recommendations: The comprehensive performance advantages of spray-dried process make it the preferred choice for most formulation scenarios; flash-dried products can be used for specific application scenarios, but disintegration performance risks need to be fully evaluated, avoiding use in high hardness formulations. In summary, formulation companies should select appropriate MCC types according to specific formulation requirements. For formulation companies sourcing microcrystalline cellulose, spray-dried DESU® Microcrystalline cellulose—a pharmaceutical-grade, NF/USP/EP/JP-compliant excipient supplied in bulk by a trusted China-based manufacturer—serves as a reliable choice for most oral solid dosage forms.

DESU® Series Evaluation Based on Wet/Dry/Direct Compression 1. Introduction Oral solid dosage form preparation processes mainly include wet granulation, dry granulation, and direct compression, with significantly different excipient performance requirements for different processes. Wet granulation requires excipients with good water absorption and granulation properties; dry granulation requires excipients that maintain good flowability and compressibility after being compressed into granules; direct compression imposes higher requirements on excipient flowability and compactibility. DESU® Microcrystalline cellulose (MCC), as a core pharmaceutical microcrystalline cellulose excipient for tablets, shows obvious differentiated characteristics in process adaptability among different grades. DESU® microcrystalline cellulose series covers DESU® Microcrystalline cellulose PH-101, DESU® Microcrystalline cellulose PH-102, DESU® Microcrystalline cellulose PH-200, and other grades, each optimized for performance targeting different formulation processes. DESU® MCC PH-101 has a finer particle size, suitable for wet granulation, dry granulation, and direct compression processes; DESU® MCC PH-102 is a commonly used grade, balancing flowability and compactibility, suitable for direct compression; DESU® MCC PH-200 is a large particle size grade with super flowability, ideal for high-speed direct compression processes. This study establishes excipient selection strategies under different process conditions through systematic formulation process evaluation, providing scientific basis for process development and excipient selection by formulation companies. 2. Experimental Methods 2.1 Wet Granulation Process Evaluation Atorvastatin calcium tablets were used as model drugs, using wet granulation and fluid bed drying process. Formulation composition: Atorvastatin calcium 10.0%, MCC 20.0% (Microcrystalline cellulose pharmaceutical grade), Lactose 68.0%, Calcium carbonate 10.0%, Croscarmellose sodium 2.0%, Hydroxypropyl cellulose 5.0%(binder). Process flow: Premixing→ Granulation(spraying 5% hydroxypropyl cellulose aqueous solution)→Fluid bed drying→Sizing→Final blending→Compression. Three main compression pressure gradients were set, and tablet hardness, disintegration time, and dissolution profile were measured. 2.2 Dry Granulation Process Evaluation Apixaban tablets were used as model drugs, using dry granulation and compression process. Formulation composition: Apixaban 5.0%, MCC 20.0%, Lactose 72.0%, Crospovidone 2.0%, Sodium stearyl fumarate 1.0%. Process flow: Premixing→ Dry granulation(roller speed 2.0 rpm, hydraulic pressure 50 bar)→ Sizing→ Final blending→ Compression. Granule flowability, tablet hardness, disintegration time, and content uniformity were measured. 2.3 Direct Compression Process Evaluation Amlodipine besylate tablets were used as model drugs, using powder direct compression process. Formulation composition: Amlodipine besylate 5.0%, MCC 25.0%, Lactose 68.0%, Croscarmellose sodium 1.5%, Magnesium stearate 0.5%. Process flow: Powder mixing→ Direct compression. Multiple main compression pressure gradients were set, and blend flowability, tablet weight variation, hardness, friability, and disintegration time were measured. 3. Results and Discussion 3.1 MCC Selection in Wet Granulation Process During wet granulation, MCC's water absorption and granulation properties are key performance indicators. Table 1 shows the performance comparison of MCC PH-101 from different sources in atorvastatin calcium tablet wet granulation process. Table 1 Performance Evaluation of Atorvastatin Calcium Tablets (Wet Granulation) Evaluation Item DESU® MCC PH-101 Asian Brand European Brand American Brand Compressibility Ranking Best Second best Third Fourth Disintegration Performance Good Good Good Good Dissolution Curve Similarity (f2) >50 >50 >50 >50 In atorvastatin calcium tablet studies, DESU® MCC PH-101 showed excellent compressibility, with the highest tablet hardness under the same main compression pressure. This is attributed to DESU® MCC PH-101's finer particle size (D50 approximately 50 um) and higher specific surface area, which can form more uniform granule structures with water-soluble binders during wet granulation, thus showing better compactibility during compression. All sources met requirements for dissolution curve similarity(f2>50), indicating quality equivalence. Selection recommendation:​ For wet granulation processes, DESU® MCC PH-101 is preferred, as its fine particle size characteristics are beneficial for granulation and compression compactibility. 3.2 MCC Selection in Dry Granulation Process Dry granulation process imposes dual requirements on MCC flowability and compressibility. Table 2 shows the performance comparison of MCC PH-102 in apixaban tablet dry granulation process. Table 2 Performance Evaluation of Apixaban Tablets (Dry Granulation) Evaluation Item DESU® MCC PH-102 Asian Brand European Brand American Brand Compressibility Ranking Second best Best Third Fourth Disintegration Performance Ranking First First Third Third Content Uniformity (A+2.2S) <5 <5 <5 <5 In apixaban tablet studies, DESU® MCC PH-102 showed outstanding disintegration performance, comparable to Asian Brand and superior to European and American Brands. After dry granulation, granule density increases and lubricant sensitivity differences are diminished, with content uniformity of tablets prepared with four MCC products meeting requirements(A+2.2S<5). Notably, dry granulation process can effectively reduce MCC sensitivity to lubricants and improve process robustness. Selection recommendation:​ For dry granulation processes, DESU® MCC PH-102 or DESU® MCC PH-112 can be selected, both having advantages in disintegration performance; for moisture-sensitive drugs (MCC for moisture-sensitive API formulations), DESU® MCC PH-112 is preferred (loss on drying<0.6%, Low moisture microcrystalline cellulose≤1.5%). 3.3 MCC Selection in Direct Compression Process Direct compression process imposes the highest requirements on MCC flowability and compactibility. Figure 1 shows the performance positioning of different MCC grades in direct compression processes. Figure 1 Performance Positioning of Different MCC Grades in Direct Compression Process In direct compression processes, DESU® MCC selection needs to comprehensively consider the balance of flowability and compactibility. DESU® MCC PH-102 is the commonly used grade, balancing flowability and compactibility, being the most commonly used direct compression excipient; DESU® MCC PH-200 is a large particle size grade with super flowability, suitable for high-speed tablet presses(>40,000 tablets/hour); DESU® MCC 702 has both super flowability (Spray-dried porous MCC with superior flowability) and excellent compactibility, making it a high-end choice for high-speed direct compression processes. Table 3 Direct Compression Process MCC Selection Matrix MCC Grade Particle Size Characteristics Flowability Compactibility Application Scenarios DESU® MCC PH-101 Fine powder (D50~50 μm) Medium Excellent Low-pressure direct compression, fragile APIs DESU® MCC PH-102 Medium (D50~100 μm) Good Good Conventional direct compression process DESU® MCC PH-200 Large particles (D50~200 μm) Super Good High-speed direct compression (>40,000 tablets/hour) DESU® MCC 702 Special particle size Super Excellent High-speed direct compression (>50,000 tablets/hour) In amlodipine besylate tablet direct compression process evaluation, DESU® MCC PH-102 showed no significant difference in compressibility compared to Asian, European, and American Brand products; in disintegration performance, DESU® was comparable to European Brand and superior to Asian and European Brands. Selection recommendations: Conventional direct compression process:​ DESU® MCC PH-102 is preferred, balancing flowability and compactibility (MCC as filler and binder for tablet manufacturing). High-speed direct compression(>40,000 tablets/hour):​ DESU® MCC PH-200 or DESU® MCC 702 is preferred. Low-pressure direct compression(fragile APIs):​ DESU® MCC PH-101 is preferred, with better process robustness. 3.4 MCC Selection Strategy for Different Processes Based on the above research results, DESU® MCC selection strategies for different formulation processes are established: Wet Granulation Process: First choice DESU® MCC PH-101: Fine particle size is beneficial for granulation, with optimal compactibility. Second choice DESU® MCC PH-102: Suitable for wet granulation with higher flowability requirements. Dry Granulation Process: First choice DESU® MCC PH-102: Excellent disintegration performance, with hardness RSD<5% after dry granulation. Second choice DESU® MCC PH-102: Suitable for wet granulation with higher flowability requirements. Direct Compression Process: Conventional direct compression: DESU® MCC PH-102 (most commonly used). High-speed direct compression: DESU® MCC PH-200 (super flowability) or DESU® MCC 702 (dual superior flowability and compactibility). Low-pressure direct compression: DESU® MCC PH-101 (best compactibility at low pressure). Figure 2 MCC Grade Selection for Different Formulation Processes 4. Conclusion This study established selection strategies for DESU® microcrystalline cellulose series under different process conditions through systematic formulation process evaluation: (1) Wet granulation process: DESU® MCC PH-101 has optimal compressibility, and its fine particle size characteristics are beneficial for granulation and compression compactibility, making it the preferred excipient for wet granulation processes. (2) Dry granulation process: DESU® MCC PH-102 has excellent disintegration performance, and dry granulation can reduce lubricant sensitivity, with content uniformity meeting requirements; DESU® MCC PH-112 is suitable for dry granulation of moisture-sensitive drugs. (3) Direct compression process: DESU® MCC PH-102 is the standard choice for conventional direct compression; DESU® MCC PH-200 is suitable for high-speed compression with its super flowability; DESU® MCC 702 has both super flowability and excellent compactibility, making it an ideal choice for high-end direct compression processes. In summary, DESU® Microcrystalline cellulose series has been differentially designed for different formulation processes. Through scientific selection strategies, it can provide formulation companies with excipient solutions adapted to different process needs, improving formulation development efficiency and product quality. (Microcrystalline cellulose NF/USP/EP/JP compliant)