Release science
Engineered pellet technologies.
Fluid-bed coating and layering built for immediate release, gastro-resistant enteric delivery, extended diffusion, and multi-component fills.
Why formulation scientists choose multiparticulates
Unlike a single-unit tablet, pellets spread through the gastrointestinal tract once the capsule shell dissolves.
Less inter-subject variability. Multiparticulates empty gradually through the pylorus, whether the stomach is fed or fasted, which avoids a single plasma spike.
Lower dose-dumping risk. The dose sits across hundreds of beads. A coating flaw on one pellet does not release the whole dose.
Incompatible actives can share a capsule. Each drug is coated on its own pellet population, then blended, so the actives do not touch.
IR
Immediate Release Pellets (IR)
Rapid Active Dissolution & Maximized Bioavailability
Engineered for rapid disintegration and high initial drug dissolution within the stomach or upper duodenal tract. Ideal for single-active immediate therapy or as the prompt-release priming fraction in dual-release fixed-dose combination capsules.
Mechanism
Active pharmaceutical ingredients are layered as a micronized or solubilized solid dispersion onto neutral starter cores using hydrophilic binders. A thin water-soluble protective seal minimizes friability while allowing dissolution medium to instantly wet and solubilize the active matrix.
Rapid aqueous wetting and dissolution of the active drug layer in physiological fluids.
- High drug loading efficiency (up to 50% w/w)
- Immediate active dissolution profiles compliant with pharmacopoeial monographs
- Smooth spherical geometry ensuring volumetric capsule fill precision
- Protective sub-coating to safeguard labile actives from atmospheric moisture
Starter cores
- Neutral Sugar Spheres (Mesh 20#24, 24#30, 30#40)
- Microcrystalline Cellulose (MCC) cores
Coating systems
- Aqueous polymer binder systems
- Water-soluble protective seal coats
Analytical focus
Dissolution rate, assay, related substances, and content uniformity across single capsule weights.
Typical applications
- Cardiovascular agents (Atorvastatin, Clopidogrel, Rosuvastatin)
- Antifungals (Itraconazole solid dispersion)
- Antiemetic priming doses (Domperidone)
EC
Enteric Coated / Delayed Release Pellets (EC)
Gastric Acid Protection & Site-Specific Intestinal Delivery
Gastro-resistant multiparticulates engineered to withstand the acidic environment of the stomach without active release, followed by dissolution upon reaching the neutral-to-alkaline intestinal tract.
Mechanism
An alkaline sub-coating is applied over the active drug layer to prevent chemical interaction between acid-labile molecules (such as benzimidazole PPIs) and functional polymers. Subsequently, a calibrated functional layer of pH-dependent enteric polymers is uniformly applied in a Fluid Bed Coater.
pH-dependent polymer barrier mechanism. Polymer remains insoluble in acidic gastric environment, protecting the active core, followed by dissolution and drug release in intestinal pH conditions in accordance with pharmacopoeial monograph specifications.
- Gastro-resistant enteric barrier protecting acid-labile active substances
- Dissolution upon pyloric transit into the small intestine
- Consistent gastric emptying compared to monolithic single-unit enteric tablets
- Reduced mucosal irritation due to widespread multiparticular distribution
Starter cores
- Neutral Sugar Spheres (Mesh 18#20, 20#24, 24#30)
- MCC cores
Coating systems
- Gastro-resistant enteric acrylic polymer dispersions
- Phthalate-based enteric polymers
- Functional plasticized polymer systems
Analytical focus
Acid resistance stage followed by buffer stage dissolution, degradation products, moisture content by KF.
Typical applications
- Proton Pump Inhibitors (Omeprazole, Pantoprazole Sodium, Rabeprazole Sodium, Esomeprazole, Lansoprazole)
SR
Sustained / Extended Release Pellets (SR / ER)
Controlled Diffusion Over Extended GI Transit
Multiparticulate systems designed to deliver controlled, uniform drug release over an extended duration, smoothing blood plasma curves and reducing dosing frequency.
Mechanism
Active-layered pellets are encapsulated within a polymeric semi-permeable membrane containing diffusion matrix polymers blended with water-soluble pore formers to establish calibrated channels for controlled active diffusion.
Controlled membrane diffusion. Drug release occurs across changing physiological conditions in accordance with target release specifications.
- Minimization of dose-dumping risk through multiparticulate dispersion
- Extended pharmacokinetic release profile designed for sustained therapeutic effect
- Independent transit through pylorus regardless of meal timing
- High reproducibility of in-vitro release kinetics across production batches
Starter cores
- Neutral Sugar Spheres (Mesh 16#20, 18#20, 20#24)
- Inert MCC seeds
Coating systems
- Functional ethylcellulose barrier systems
- Insoluble polymer membranes with calibrated pore formers
Analytical focus
Multi-point dissolution profiling, membrane uniformity, friability, accelerated stability.
Typical applications
- Antiemetics & prokinetics (Domperidone SR 30%)
- NSAIDs (Diclofenac SR, Ketoprofen SR)
- Urologicals (Tamsulosin SR)
- Neuropsychiatrics (Venlafaxine SR)
COMBINATION
Combination / Fixed-Dose Blended Pellets
Physical Chemical Segregation of Incompatible Actives in Single Fill
Precision volumetric blending of two or more distinct multiparticulate populations into a single capsule dosage form. Allows simultaneous delivery of incompatible active pharmaceutical ingredients or combining distinct release profiles (such as Immediate Release + Sustained Release).
Mechanism
Individual actives are synthesized on separate pellet populations with custom individual protective coatings, eliminating direct physical or chemical contact between mutually incompatible APIs. The finished pellet populations are homogenously blended in our 1,500 L SS-316 Double Cone Blender for uniform volumetric capsule filling.
Independent, tailored release kinetics for each constituent pellet population within the same gastrointestinal transit.
- Chemical incompatibility mitigation without complex multilayer tableting
- Dual release dynamics: Rapid initial priming + prolonged maintenance in one capsule
- Broad therapeutic synergy across gastroenterology, cardiology, and hematinic fields
- Uniform capsule fill weight and active distribution supported by calibrated spherical geometry
Starter cores
- Matched-diameter Neutral Sugar Spheres
- Placebo dummy spacing cores
Coating systems
- Independent enteric, sustained-release, and moisture-barrier polymer films applied per drug population
Analytical focus
Independent assay for each active, separate dissolution profiles, blend uniformity analysis, and content uniformity.
Typical applications
- PPI Enteric + Prokinetic Sustained Release (Pantoprazole EC + Domperidone SR)
- Antiplatelet + Lipid Lowering (Clopidogrel IR + Atorvastatin IR)
- Multi-mineral Haematinics (Ferrous Sulphate + Folic Acid + Zinc Sulphate)
SUGAR
Sugar Spheres / Non-Pareil Seeds
High-Sphericity Neutral Starter Cores for Precision Layering
Manufactured in our dedicated First-Floor cleanroom with dedicated machinery and experienced operators. These pharmaceutical sugar spheres provide high mechanical integrity and tight particle size distributions necessary for modern fluid-bed coating.
Mechanism
Formulated strictly from pharma-grade sucrose and maize starch according to pharmacopoeial monographs (IP, BP, USP, Ph. Eur.). Layered systematically to create dense, spherical cores with smooth surface characteristics for optimal coating polymer adhesion.
Inert carrier core. Dissolves in aqueous fluids without interfering with active ingredient release or absorption.
- High mechanical integrity minimizing bead attrition during fluidization
- Consistent spherical geometry supporting automated capsule filling
- Broad mesh size availability from coarse 14#18 down to fine 60#80
- Tight sieve distribution minimizing batch-to-batch variation in finished drug load
Starter cores
- Pharma Grade Sucrose & Starch Carrier Matrix
Coating systems
- Ready-to-coat neutral substrate
Analytical focus
Sieve classification, bulk density, friability testing (Roche friabilator), microbiological limits, loss on drying (LOD).
Typical applications
- Universal starter core for IR, EC, and SR pellet manufacturing across domestic and global formulation facilities
DUMMY
Neutral Placebo Calibrated Pellets
Volumetric Fill Modulators & Inert Spacers
Precision calibrated neutral placebo spheres manufactured with dedicated equipment and operators. Designed to serve as volumetric compensating spacers in capsule filling and as stable process validation substrates.
Mechanism
Chemically inert multiparticulate beads formulated to match the density, sphericity, and flowability of functional active drug pellets. Enables formulation chemists to adjust fill volumes in capsule shells (Size 00, 0, 1, 2) without altering drug potency.
Completely inert and non-reactive in biological fluids.
- Calibrated mesh sizes (12#16, 12#18, 16#20)
- Bulk density matched to active pellet formulations
- Smooth surface finish preventing electrostatic adherence
- Manufactured under strict pharmaceutical cleanroom controls
Starter cores
- Pharma grade neutral matrix excipients
Coating systems
- Uncoated or sealed neutral exterior
Analytical focus
Particle size distribution, flow properties (Hausner ratio, Carr’s index), bulk density, and heavy metals.
Typical applications
- Volumetric compensation in combination capsules
- Machine calibration on automated capsule filling equipment
Custom release kinetics and feasibility trials.
Formulation R&D develops drug-loading levels, polymer barrier profiles and multi-active blends for a specific capsule fill.