Hard capsules are widely used in the supplement, pharmaceutical and cosmetic industries. It is crucial that the encapsulation process is carried out correctly and that the right capsules are selected. The most popular are hard gelatin capsules. What is worth knowing about them, where are they used and what are their greatest advantages?
What are hard capsules?
Hard capsules consist of two cylindrical elements that snap together when one is inserted into the other. They can be filled with substances in liquid or solid form. Hard capsules are valued for precise dosing, stability and the ability to mask the taste and smell of active ingredients.
What are hard capsules made of?
Hard capsules are mainly made of gelatin, water, glycerol and excipients. They can be made from pork, beef or fish gelatin. The encapsulation process is not simple, so it should be carried out by reputable producers. Business IOC specializes in the production of hard capsules, using modern technologies in accordance with GMP and ISO 22000 standards, minimizing or eliminating excipients.
Advantages and disadvantages of hard capsules
| Advantages | Disadvantages |
|---|---|
| Quickly dissolves in the stomach | Sometimes they may cause stomach discomfort (v IOC we try to eliminate excipients). |
| Release of contents approximately 3 minutes after taking | They may be more difficult to swallow (it is recommended to select the appropriate size). |
| Masking unpleasant taste | Gelatin not suitable for vegans (IOC also offers plant capsules). |
| Possibility of controlled drug release | They may contain allergens such as gluten (incl IOC can be eliminated by appropriate selection of ingredients). |
| Possibility of filling with powders, granules, dragees, liquids and pastes | |
| Protection of sensitive ingredients from light and air |
Hard capsules – sizes
Hard capsules are available in sizes from 0,06 ml to 3,6 ml. For example, size 3 capsules are very popular among dietary supplements. These capsules can be filled with a variety of substances, making them versatile and can be tailored to the specific needs of consumers.
How to take hard capsules?
Taking hard capsules is simple. Please follow the instructions on the dietary supplement leaflet in their packaging. The capsules are usually swallowed whole with plenty of liquid. It is also important that the blistering process is carried out professionally, providing the capsules with an appropriate visual and functional effect as well as protection against sunlight and air.
Additional technological aspects
Capsules can be enriched with preservatives, fillers, flavors, sweeteners and dyes. They can also be covered with a film that changes the rate of release of the active substance. Brand and dosage information can be printed on the capsules, making product identification easier.
Advanced technologies for the production of hard capsules
| Etap | Description |
|---|---|
| Capsule formation | Finger-shaped molds immersed in hot gelatin solution create a thin layer. |
| Drying | The gelatin layer is dried under controlled conditions to ensure the proper hardness of the capsule. |
| Separating and trimming | The capsules are removed from the molds and cut to the appropriate length. |
| Assembly and filling | The capsule parts are assembled and filled with medicinal ingredients or nutraceuticals. |
Why us?
Why choose IOC as a contract manufacturer of your supplement?
Hard capsules vs. tablets and soft capsules
| Comparison | Hard capsules | Pills | Soft gelatin capsules |
|---|---|---|---|
| Composition | Powder or granules, enclosed in a hard gelatin shell | Compressed powder or granules | Liquids or semi-solids in elastic gelatin |
| Release | Rapid release in the digestive system | Slower release, solubility dependent | Quick release, especially for liquids |
| Advantages | Easy to swallow, no distinct taste | Possibility of dividing and precise dosing | Perfect for liquid substances, gentle on the digestive tract |
| Disadvantages | You can't always figure them out; not suitable for vegans | Unpleasant taste, slower absorption | More expensive to produce, may be difficult to swallow for some |
Summation
The production of hard and soft capsules requires advanced technologies and rigorous quality standards. IOC as a leading manufacturer of hard capsules, it offers a wide range of products tailored to the individual needs of customers. Hard capsules are valued for precise dosing, quick release of active ingredients and the ability to mask taste.
For more information, please see our entry on hard capsules.
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Interesting fact: Microperforations in capsules
In the hard capsule manufacturing process, it is possible to create microperforations on the capsule surface. Microperforations are sometimes used in modified release capsules to control the speed of capsule dissolution and delivery of the active ingredient. Precisely placed holes allow for even absorption of moisture and optimized release of active ingredients.
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How is it possible that hard capsules, an invention from the 19th century, are still the foundation of modern pharmacy? Discover the fascinating world of hard capsules, their history, manufacturing processes, the materials that make them so unique, and the innovations that give them new life in the 21st century. Discover why hard capsules are an indispensable part of therapy for both patients and professionals.
Capsules are one of the most popular and oldest forms of administering drugs and dietary supplements. Their versatility, ease of use and technological possibilities make them an inseparable element of modern pharmacy. Hard capsules are of particular importance, and thanks to their properties, they are widely used in both the pharmaceutical industry and pharmacy practice. This article presents a comprehensive look at hard capsules, their history, production technology, materials used for their production and the latest trends and innovations in this field. History and Development of Hard Capsules The first mentions of capsules come from the 1847th century, when in XNUMX James Murdoch patented a two-part gelatin capsule. This was a breakthrough in drug administration, allowing for masking the unpleasant taste of active substances and facilitating their dosing. In subsequent years, the technology of producing hard capsules was improved, introducing new materials and production methods, which allowed for the expansion of their applications.
Hard Capsule Production Technology Manufacturing Process Hard capsule production is based on the immersion method. It involves immersing special pins (pins) in a solution of gelatin or other gelling material. This process consists of the following stages: Immersion of Pins: Metal pins of an appropriate shape are immersed in a heated solution of gelling material. Rotation and Drying: After being pulled out of the solution, the pins rotate to ensure even distribution of the material and formation of the capsule wall. They are then dried under controlled temperature and humidity conditions. Removal of Bodies and Caps: After drying, the resulting capsule blanks (bodies and caps) are carefully removed from the pins. Trimming: The edges of the capsules are trimmed to the desired length, ensuring precise fit of the body and cap. Joining and Quality Control: The bodies and caps are joined to form complete capsules. They are then quality checked for dimensions, tightness and structural integrity. Capsule Filling Hard capsules are filled using specialist encapsulation machines that enable precise dosing of active ingredients in the form of powders, granules, pellets or microtablets. This process requires precise calibration to ensure uniformity of dose in each capsule.
| Etap | Description |
|---|---|
| Mandrel Dipping | Metal pins are immersed in a heated solution of gelling material. |
| Turning and Drying | After immersion, the mandrels are rotated and dried under controlled conditions. |
| Removing Bodies and Lids | After drying, the semi-finished products (bodies and lids) are carefully removed from the mandrels. |
| Pruning | Capsules are cut to the desired length, ensuring the body and lid fit. |
| Connection and Quality Control | The bodies and lids are assembled and then subjected to quality control. |
Fun fact: The phenomenon of "encapsulation in a capsule"
Some advanced formulations use the "capsule encapsulation" method, which involves placing a smaller capsule inside a larger one. This allows for the separation of ingredients that may be incompatible with each other, or for the introduction of additional release features, such as delivering one substance in the stomach and another in the intestine.
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Hard Capsule Sizes
| Size | Volume (ml) | Length when closed (mm) | Outer diameter (mm) |
|---|---|---|---|
| 5 | 0.13 | 11.1 | 4.91 |
| 4 | 0.2 | 14.3 | 5.31 |
| 3 | 0.27 | 15.9 | 5.82 |
| 2 | 0.37 | 18.0 | 6.35 |
| 1 | 0.48 | 19.4 | 6.91 |
| 0 | 0.67 | 21.7 | 7.65 |
| 00 | 0.95 | 23.3 | 8.53 |
| 000 | 1.36 | 26.14 | 9.91 |
Interesting fact: The influence of humidity on the production process
Humidity in hard capsule production rooms must be strictly controlled, often maintained at 20-25%. Otherwise, the gelatin may absorb too much moisture, which will cause the capsules to soften, deform or be difficult to fill. On the other hand, too low humidity can lead to capsules cracking, which reduces their durability.
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Fun fact: The secret to wall thickness uniformity
The wall thickness of hard capsules must be exceptionally uniform to ensure precise drug release and adequate mechanical strength. This is achieved by specific, repeatable rotation of the pins during immersion in gelatin, which allows for even distribution of the material. This uniformity is monitored by laser sensors, which ensures consistent quality of the final product.
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Materials Used in Production Gelatin Traditionally, hard capsules are made from animal gelatin, mainly from the collagen of cattle or pig skin and bones. Gelatin is a material: Biodegradable and Biocompatible: Well tolerated by the human body. Flexible and Durable: Allows the formation of thin but durable capsule walls. Soluble in Gastric Juice: Allows rapid release of the active substance after consumption. Alternative Materials In response to the needs of people with dietary restrictions and religious requirements, capsules from plant materials have been developed: Hydroxypropyl methylcellulose (HPMC): A cellulose derivative, free from animal components, stable in various pH conditions. Pullulan: A polysaccharide obtained from the fermentation of starch by fungi, characterized by high transparency and resistance to oxygen. Modified Starch: Used to produce slowly dissolving or delayed release capsules.
Support at Every Stage of Production
W International Organic Company (IOC) we do not only produce hard capsules – we support you at every stage, from concept to final product. Our team of formulation experts, food technologists and production specialists work with you to develop the perfect composition of the supplement, in line with the latest market trends and legal regulations. We also help in selecting the right raw materials, optimizing production costs and in the packaging and labeling process. With us, your product not only meets the highest standards, but is ready to be introduced to the market without any complications. Trust our experience and comprehensive support.
Microencapsulation – Encapsulation of active ingredients in microcapsules for better stability and protection. Nano-micellization – Improving the bioavailability of active ingredients by creating nanoparticles. Liposomal technology – Transport nutrients to cells through liposomes for increased effectiveness. Collagen peptides – Advanced technologies for obtaining collagen peptides with high absorption. Atelocollagen – Production of pure collagen supporting the health of skin, hair and joints. Supercritical CO2 extraction – An innovative method of obtaining plant extracts, environmentally friendly. Spray drying – A technique for drying liquid substances, obtaining powders with high stability. Formulation of lipophilic and hydrophilic ingredients – Combining fat- and water-soluble ingredients for complex supplements. Production of probiotics with thermal protection – Stability and viability of probiotic cultures at high temperatures. Technologies for manufacturing gel capsules (Softgel) – Perfect soft capsules for enclosing oils and liquid active substances.Delayed release capsules (DRcaps) – Controlled release of active substances at the right moment.and many more …
Advanced Manufacturing Technologies
W International Organic Company (IOC) we use modern production technologies that will distinguish your product from the competition. We offer, among others, microencapsulation, nano-micellization and liposomal techniques that increase the bioavailability of active substances. Thanks to these innovative solutions, your hard capsules will be more effective and more attractive to consumers, guaranteeing an advantage on the market. Trust our experience and let us create a supplement together that meets the highest standards of quality and innovation.
Comparison of Materials Used to Produce Capsules
| Composition | Origin | Advantages | Disadvantages | Destiny |
|---|---|---|---|---|
| Gelatine | Animal (skin, bones) | Biodegradable, biocompatible, soluble in gastric juice | Sensitive to moisture, not suitable for vegans | Traditional hard capsules |
| Hydroxypropyl methylcellulose (HPMC) | Vegetable | Stable at various pH levels, free from animal ingredients | Higher expense production | Capsules for vegans and vegetarians |
| pullulan | Starch fermentation | High transparency, oxygen resistance | High price | Vegetable capsules |
| Modified Starch | Vegetable | Slow dissolving, delayed release | Limited stability in some conditions | Delayed release formulations |
Interesting fact: Hard capsules in inhalers
Hard capsules are also used in some powder inhalers, such as the popular DPI (Dry Powder Inhalers). In this case, capsules filled with powder are pierced and the patient inhales the content. The capsule material must be very precisely selected to avoid fragmentation during piercing, which could enter the respiratory system.
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Interesting fact: The impact of UV lighting on the durability of capsules
The impact of ultraviolet light is a key factor in the durability of hard capsules. For example, some active ingredients can be degraded by UV light, which leads to a reduction in their effectiveness. Therefore, capsules with added dyes are used in the production and storage process, which block UV light, protecting the active ingredient.
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Interesting fact: Width of capsule dimension tolerance
Hard capsule production requires very precise dimensional control. The tolerance on the length of the capsule body and cap is only about ±0,15 mm. This level of precision is necessary to ensure that the capsule parts fit perfectly and prevent them from separating during transport or use.
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| shoe | Description |
|---|---|
| Formulation Flexibility | Possibility of introducing a wide range of active substances, including sensitive substances. |
| Patient Comfort | Masking of taste and smell, easy to swallow thanks to the smooth surface of the capsule. |
| Precise Dosage | Dose uniformity and possibility of dose adjustment, especially for pediatrics and geriatrics. |
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Advantages and Applications of Hard Capsules Formulation Flexibility Hard capsules enable the introduction of a wide range of active substances, including: Light or Moisture Sensitive Substances: Thanks to the protective properties of the capsule material. Mixtures of Substances: They allow the combination of several ingredients in one dose. Release Modifying Formulations: By using pellets with different coatings, the drug release profile can be controlled. Patient Comfort Masking Taste and Odor: Capsules effectively hide unpleasant organoleptic characteristics of active substances. Ease of Swallowing: Smooth surface and streamlined shape make it easier to take the drug. Precise Dosing Dose Uniformity: Precise control of the filling process ensures a constant amount of the active substance in each capsule. Possibility of Dose Adjustment: Particularly important in pediatric or geriatric therapy, where doses must be individually adjusted.
Fun fact: The history of using alternatives to gelatin
The development of alternative materials to gelatin in hard capsules began in the 70s, but it was not until 1989 that HPMC capsules were introduced and gained popularity as a vegan-friendly option. Earlier attempts involved starch modifications, but these did not meet the required stability and quality standards for pharmaceutical applications.
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Interesting fact: Capsules that protect the intestinal microbiota
Some hard capsules are designed to open only in the small intestine, where they release substances that support the gut microbiota. They are specially coated with materials that are resistant to stomach acids, so the contents are protected until they reach the right place in the digestive tract.
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Fun fact: Static effect in capsule production
When producing capsules with dry powders, the problem is often the electrostatic charge of the ingredients, which can lead to them sticking to the production equipment. To prevent this, special antistatic substances are added to the powders, which minimize this effect, ensuring uniform filling of the capsules.
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Technological Challenges and Innovation Capsule Stability Hygroscopicity: Gelatin and some plant materials are sensitive to moisture, which can affect the stability of the capsule and its contents. The solution is to use protective packaging with desiccants and control storage conditions. Interactions with Active Ingredients: Some active ingredients can react with the capsule material. Compatibility studies and possible coating of the substance help to avoid this problem. Innovations in Capsule Design Gastric Protective Capsules: Special acid-resistant coatings enable delivery of the drug to the small intestine. Modified Release Capsules: Technology allows to control the rate and location of the release of the active substance. Microencapsulation: Enclosing the active substance in microcapsules inside a hard capsule increases stability and release control. Advanced Filling Methods Multilayer Technologies: Allows to place several active substances with different release profiles in one capsule. Inhalation Systems: Hard capsules are used in some powder inhalers where the capsule is pierced and the patient inhales the released powder.
Personalization and Formulation Flexibility in IOC
W International Organic Company (IOC) we know how important it is to fully customize hard capsules to meet your brand's expectations. We offer a flexible approach to formulation - you can choose active ingredients in powder or granulate form, adjust their concentrations and add unique ingredients that will distinguish your product. What's more, we personalize the appearance of capsules - from size, through color, to type of coating. With us, you can be sure that your product will be perfectly suited to the needs of the market and your vision.
Standards and Regulations Capsule Sizes Hard capsules are available in a variety of sizes, from 000 (largest) to 5 (smallest). The size selection depends on the volume and density of the active substance and the intended dose. Quality Standards The production of hard capsules must meet strict quality standards, set by pharmacopoeias and regulatory bodies: Mass Uniformity: The mass variation of the capsules must be within specified limits. Dissolution and Release: The capsules must meet the requirements for disintegration time and release profile of the active substance. Microbiological Purity: The materials used in the production of capsules must be free from microbiological contamination.
| Standard | Description |
|---|---|
| Mass Uniformity | Capsule weight variations must be within certain limits. |
| Solubility and Release | Capsules must meet requirements regarding disintegration time and release profile of the substance. |
| Microbiological purity | Materials used for production must be free from microbiological contamination. |
| Capsule Size | Capacity (ml) | Application |
|---|---|---|
| 000 | 1.37 | Large doses of medications and supplements, less frequently used due to difficulty swallowing. |
| 00 | 0.95 | Most commonly used, suitable for high doses. |
| 0 | 0.68 | Universal, used in dietary supplements and medicines. |
| 1 | 0.5 | Smaller doses of the substance, suitable for children. |
| 2 | 0.37 | For small doses of medications, easy to swallow. |
| 3 | 0.3 | For minimal doses, easiest to swallow. |
| 4 | 0.2 | Very small doses, specialized use. |
| 5 | 0.13 | The smallest capsules available, used in pediatrics or for microdoses. |
Quality Certificates and Safety Standards
Production of dietary supplements in International Organic Company (IOC) is a guarantee of the highest quality and safety standards. Our plants meet GMP, ISO 22000, HACCP and many other standards, which ensures full compliance with international regulations. Each stage of hard capsule production, from raw materials to the finished product, is rigorously controlled, so that you can be sure that you are offering your customers the highest quality supplements. Your trust is our priority, which is why our products meet the most demanding market standards.
The Future of Hard Capsules Personalization of Therapy Personalized Pharmacy: Development of 3D printing technology allows the production of capsules with individually adjusted doses and release profiles. Monitoring of Therapy: Integration of microsensors in capsules allows to track the intake of the drug by the patient. Sustainable Development Biodegradable Materials: Research into new materials of plant or microbiological origin, which are friendly to the environment. Waste Reduction: Optimization of production processes to minimize the consumption of raw materials and energy. Innovative Forms of Drug Delivery Nanotechnology: Use of nanoparticles to improve the bioavailability of active substances in hard capsules. Multifunctional Systems: Capsules capable of simultaneous delivery of several active substances with different therapeutic effects.
Summary Hard capsules remain a key element in the delivery of drugs and dietary supplements. Their versatility, adaptability and continuous technological innovation make them irreplaceable in many areas of pharmacy. Both manufacturers and pharmacists appreciate their advantages, and patients benefit from the convenience and effectiveness of therapy provided by hard capsules. In the face of the dynamic development of science and technology, hard capsules have a promising future ahead of them, offering new possibilities in the field of therapy and patient care.