Capsules represent a solid pharmaceutical form where active ingredients or additives are enclosed within hollow shells or flexible gelatin coverings. They are classified into various types, including hard-shell capsules, soft-shell capsules, extended-release capsules, modified-release capsules, and enteric-coated capsules.
What are pill capsules made of? The outer capsule shells are typically composed of gelatin, plant-based cellulose, or related derivatives, engineered to dissolve progressively after entering a human body. Capsules serve to conceal the bitter taste or odor of medications, shield contents from humidity, oxidation, and light degradation, and facilitate controlled drug release for enhanced therapeutic efficacy.
The earliest known capsules date back to 1500 AD in Egypt. During that era, lacking pieces of equipment such as a capsule filler and a tablet presser, Egyptians encapsulated hard-to-handle medicines in digestible casings. Tuttavia, these early capsule versions were merely sealed pellets with hollow interiors. It wasnāt until 1846 that the modern two-piece hard capsule design was introduced.
The first tablet press emerged in 1840, leading to the advent of compressed tablets. In terms of capsule vs pill, while pellets offered a simpler alternative to the “drug + shell” concept, capsules endured due to their unique and indispensable advantages in drug delivery.
2.1 Capsules effectively conceal unpleasant odors of medications while enhancing their stability. By enclosing the active drug ingredient within capsule shells, external factors such as light and humidity are blocked, providing protective barriers and stabilization for pharmaceutical contents.
2.2 Capsules facilitate rapid drug absorption in the body. Since the medication is contained in powder or granular form within capsules, it bypasses the mechanical compression involved in producing tablets or pellets. Di conseguenza, the active pharmaceutical ingredient (API) in capsules disperses, dissolves, and is absorbed more efficiently in humansā digestive system.
2.3 Liquid medications can be converted into a solid form, such as softgel capsules, making them easier to consume and transport.
2.4 Capsules enable controlled or targeted drug release. By preparing the drug as coated granules or pellets and selecting appropriate shell materials, sustained-release effects can be achieved. Enteric-coated capsules ensure drug release occurs specifically in the small intestine, while controlled-release variants maintain a steady, prolonged release of medication in the intended environment.
Working differently from ancient Egyptians, we now manufacture medicines with advanced capsule filling machines and tablet press machines. The great progress in pharmaceutical equipment has allowed us to dramatically elevate the efficiency and quality of capsule manufacturing.
Capsule shells are manufactured through a multi-step process using gelatin derived from animal collagen (usually bovine or porcine).
3.1 Gelatin Preparation: Gelatin is mixed with water, plasticizers such as glycerin, and additives to form a viscous solution.
3.2 Dip-Coating: Stainless steel pins work as molds to be dipped into the gelatin solution to form the capsule halves (capsule bodies and capsule caps). The pins are precisely sized for consistent dimensions.
3.3 Asciugatura: The coated pins are rotated and dried in controlled temperature and humidity conditions to solidify the gelatin.
3.4 Stripping & Trimming: Dried capsule halves are stripped from the pins, trimmed to the correct length, and polished.
3.5 Joining: The capsule body and cap are fitted together, leaving them loosely pre-locked for easy filling.
3.6 Quality Control: Capsules undergo inspections for defects, size, moisture content, and dissolution performance.
Once empty capsule shells are manufactured, they are filled with pharmaceutical formulations by using an automatic capsule filling machineāultimately producing finished capsules. Modern capsule filling machines, such as G90 from IMA and NJP 3800D from Jinlu Packing, operate at high speeds more than filling 220,000 capsules/hour with minimal human intervention.
the NJP 3800D capsule filler filling machine
The fully automated capsule filling process ensures precise dosing, high efficiency, and compliance with cGMP. Below is a brief analysis of the capsule filling process in modern pharmaceutical production.
The process begins with loading empty capsule shells into the machineās hopper. A capsule consists of a longer sectionāthe capsule body and a shorter sectionāthe capsule cap. A vacuum or mechanical system separates caps from bodies, aligning them correctly for filling.
Most capsules are filled with powdered or granulated formulations. A contemporary capsule filler filling machine uses one of two filling principles:
Accurate dosing is critical. Some automatic capsule filler models may include load cells or real-time weight check mechanisms to ensure uniformity. Some formulations require compression to improve stability or prevent leakage.
After filling capsules with ingredient, the cap and body are rejoined by using gentle pressure. A high-performance capsule making machine ensures proper sealing without damaging shells. Filled capsules are then ejected into a collection bin.
4.5 Polishing
After finished capsule output, capsules may also pass through a polishing machine to remove excessive powder on capsule surfaces.
For further pharmaceutical packaging, finished capsules are packed into bottles or blister packs by utilizing a capsule counting and filling machine or a blister packaging machine, depending on the intended use.
The capsule filling process is highly controlled to ensure dosage accuracy, uniformity, e conformitĆ agli standard normativi. Automation reduces contamination risks while improving production capacity, making capsule filling a reliable method for solid and semi-solid drug delivery.
While capsules effectively prevent medications from dissolving prematurely in the mouth, a new challenge arises: how can we prevent them from dissolving too quickly in the stomach?
To address this issue, pharmaceutical scientists have developed enteric-coated capsules, which utilize specialized polymers such as methacrylic acid copolymer and methacrylate copolymerācommonly referred to as acrylic resin. This polymer acts like a precision-engineered “timer” embedded within the capsule shell. It ensures that the capsule remains intact in the acidic environment of the stomach, only dissolving when it encounters the alkaline conditions of the intestines. By doing so, the medication bypasses premature release in the stomach and instead becomes active in the targeted intestinal region.
Yet, reaching the intended site of absorption is just the initial phase. To ensure the drug remains effective over an extended period, the design of the capsuleās internal structure plays a crucial role. Inside these capsules are numerous tiny pellets, granules or powder. While they may appear identical, their outer coatings differ significantly. These pellets are enclosed in a specialized coating composed of high-molecular-weight organic compounds, meticulously applied to form a uniform barrier around the drug core. Once a capsule dissolves, this protective layer gradually erodes within the digestive tract, allowing the drug to be released in a controlled manner. Only when the coating fully dissolves does the core become exposed, initiating the drug release.
The thickness of this coating is a key determinant in regulating drug release. A thicker coating prolongs dissolution time, thereby delaying medication release. By fine-tuning the coatingās thickness, pharmaceutical engineers can guarantee the medication ingredient is accurately released to meet patientsā need.
Tuttavia, while a thicker coating can delay initial drug release, the coating does not inherently extend the duration of therapeutic effect. Ad esempio, ingredients might be engineered to release contents after 12 ore, but this alone does not sustain the drugās effects over that entire period. To achieve prolonged efficacy, sustained-release capsules employ a strategic approach: the ingredients inside capsules are divided into multiple groups, each coated with layers of varying thickness. This ensures a staggered release pattern, where some ingredients dissolve early, while others release the drug gradually, maintaining consistent therapeutic levels over an extended timeframe.
This sophisticated multi-layered release system exemplifies how modern pharmaceuticals optimize drug delivery, balancing precision, efficienza, and patient convenience.
Let us consider these miniature pellets being categorized into three distinct types based on their drug release characteristics. The initial category consists of rapid-dissolving pellets that lack any protective coating, allowing the active pharmaceutical ingredients to be liberated instantaneously upon administration. The intermediate category comprises moderately-coated pellets featuring a thin polymeric layer that moderately delays the drug dissolution process. The final category contains extended-release pellets enveloped in the thickest coating material, resulting in the most gradual and prolonged medication release profile.
These three varieties of pellets are then carefully encapsulated within a single gelatin capsule. Following oral ingestion, the outer capsule shell rapidly disintegrates in the gastrointestinal environment, permitting the immediate-release pellets to commence drug dissemination. The liberated active compounds are subsequently absorbed through the intestinal mucosa into systemic circulation, causing plasma drug concentrations to progressively elevate. Once therapeutic levels are attained, the pharmacological effects become manifest. Concurrently, the body’s metabolic processes begin breaking down and eliminating the medication, leading to a gradual decline in drug concentration after reaching peak levels.
Precisely at this juncture, the thinner coating of the intermediate-release pellets has substantially eroded, enabling this second wave of drug liberation to commence. As the plasma concentration from these medium-acting pellets starts its inevitable descent, the thick-coated extended-release pellets initiate their delayed activation, serving as the third phase of medication delivery.
This carefully orchestrated triphasic release mechanism ensures that therapeutic drug concentrations are maintained within the optimal window for an extended duration. Such sophisticated sustained-release capsule technology provides prolonged clinical efficacy while minimizing concentration fluctuations that could lead to subtherapeutic levels or adverse effects.
Beyond this multi-particulate sustained-release system, modern pharmaceutical science has developed numerous advanced drug delivery technologies. These include matrix systems, osmotic pumps, and biodegradable polymers that offer precise control over release kinetics. The implementation of these innovative formulations significantly enhances patient compliance by reducing dosing frequency while simultaneously optimizing therapeutic outcomes through consistent drug exposure. Such technological advancements represent important milestones in personalized medicine and optimized pharmacotherapy.
The dissolution of capsules is a highly precise and carefully controlled process, shaped by multiple factors such as the composition of the shell, the coating techniques applied, and the underlying pellet technology. For pharmaceutical manufacturers, gaining expertise in capsule formulation along with optimizing production equipment is essential to ensuring the delivery of medications not only safe and therapeutically effective but also convenient and user-friendly for patients.
By refining these elements, drug makers can enhance bioavailability, improve dosing accuracy, and ultimately achieve better patient compliance. Di conseguenza, continuous advancements in capsule design and manufacturing play a pivotal role in modern pharmaceutical development.
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Collegamenti amichevoli: Imballaggio ricco | Produttori di macchine per il riempimento di capsule
