Capsule Shell

Capsule Shell

Capsule shells play a pivotal role in the medicine and pharmaceutical industries, offering a multitude of advantages such as enhanced bioavailability, reliability, and safety.
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Description
Technical Parameters
Our Factory

 

Zhejiang Tianlong Capsule Co., Ltd. was founded in 1987 and is a professional manufacturer of hollow capsules. At present, the company has two capsule production plants and 46 hollow capsule production lines installed. The plant area is strictly planned and designed according to the GMP standard for pharmaceutical excipients. The layout is scientific and reasonable. It has passed ISO9001 quality management system certification and is registered with the FDA in the United States. The company mainly produces 00#, 00#B, 0#el, 0#, 1#, 2#, 3#, 4# and other specifications of gelatin hollow capsules and plant capsules. At the same time can provide hundreds of colors for customers to choose, but also in accordance with the customer's color card number and sample custom production, the current annual production capacity has reached 26 billion.

 

Why Choose Us

Raw materials

We offer a vertically integrated supply chain model to ensure reliable long-term supply, complete traceability, and superior quality of raw materials. Our raw materials pass through strict quality control assessments before going to the manufacturing stage.

Complete qualifications

Our plant area is strictly planned and designed according to the GMP standard for pharmaceutical excipients. We have passed ISO9001, USFDA, HALAL quality management system certification and is registered with the FDA in the United States.

OEM & ODM service

We can provide hundreds of colors for customers to choose, but also in accordance with the customer's color card number and sample custom production.

Quality guaranteed

Advanced automated equipment and facilities, strict indoor cleanliness procedures and perfect quality real-time monitoring, as well as high-quality.

 

 

Vegetarian Capsule

Vegetarian Capsule

Low water content, suitable for water sensitive components. No risk of cross-linking reaction. The structure of elastic polymer ensures the stability of the capsule and the high filling rate.

Empty Veggie Capsule

Empty Veggie Capsule

Zhejiang Tianlong Capsule Co., Ltd. was founded in 1987 and is a professional manufacturer of hollow capsules. At present, the company has two capsule production plants and 46 hollow capsule production lines installed.

HPMC Vegetarian Capsule

HPMC Vegetarian Capsule

Our high quality, high performance HPMC(hydroxypropyl-methyl-cellulose) capsules meet a wide range of lifestyle, cultural and dietary needs, and are also well suited to moisture-sensitive formulations.

Hydroxypropyl Methylcellulose Capsule

Hydroxypropyl Methylcellulose Capsule

Custom pharmaceutical grade drug in Halal natural plants cellulose print colored empty hard vegetable HPMC capsules

Vegetable Capsule Shell

Vegetable Capsule Shell

Halal food refers to food that meets Islamic Halal food standards. Islamic eating habits come from the canon. According to the canon, halal foods do not contain contraindications such as dead objects, blood and pork.

Empty Vegetable Capsule

Empty Vegetable Capsule

Our high quality, high performance HPMC (hydroxypropyl-methyl-cellulose) capsules meet a wide range of lifestyle, cultural and dietary needs, and are also well suited to moisture-sensitive formulations.

Cellulose Capsule Shell

Cellulose Capsule Shell

Custom pharmaceutical grade drug in Halal natural plants cellulose print colored empty hard vegetable HPMC capsules

Cellulose Capsule

Cellulose Capsule

Function/ The stomach dissolves, disintegrates, dissolves and absorbs rapidly in the stomach.

Vegan Gelatin Capsule

Vegan Gelatin Capsule

Our high quality, high performance HPMC(hydroxypropyl-methyl-cellulose) capsules meet a wide range of lifestyle, cultural and dietary needs, and are also well suited to moisture-sensitive formulations.

 

What Is Capsule Shell

 

Capsule shells play a pivotal role in the medicine and pharmaceutical industries, offering a multitude of advantages such as enhanced bioavailability, reliability, and safety.Gelatin shell capsules, commonly used in pharmaceuticals, are encapsulated forms that contain active pharmaceutical ingredients (APIs) within a gelatin-based shell. These capsules can be either soft or hard, depending on their formulation and intended use.

 

 
Benefits of Capsule Shell
 
01/

Dosage control
Capsule shell allow for precise control over the dosage of minerals. Manufacturers can fill the capsules with exact amounts of mineral compounds, ensuring that consumers receive the recommended daily intake without the need for multiple pills or complex dosing instructions.

02/

Extended shelf life
The protective nature of capsule shell extends the shelf life of mineral supplements. By keeping the minerals sealed away from environmental factors, the capsules help maintain the integrity of the product over time, reducing the risk of spoilage and ensuring a longer-lasting product.

03/

Versatility in formulation
Capsule shell are highly versatile and can be used to encapsulate a wide range of mineral compounds, from single minerals to complex blends. This versatility allows manufacturers to create a variety of products tailored to specific consumer needs and preferences.

04/

Compatibility with other ingredients
Minerals encapsulated in capsule shell can be easily combined with other ingredients, such as vitamins, herbs, or other supplements. This compatibility allows for the creation of multi-nutrient products that offer a comprehensive approach to health and wellness.

 

Types of Capsule Shell
 

Gelatin Capsules
Gelatin capsules are categorized into hard and soft shells. These shells are made using different manufacturing processes and usually have different shell designs; they all provide an effective and protective cover from light and atmospheric conditions for medicines or supplements. Here's a detailed overview of each type of gelatin capsule.

 

Modified Release Capsules
Modified release pharmaceutical capsules or dosage forms are used in capsules to dissolve a medicine, vitamin, or supplements over time in order for the ingredients to be released slowly and steadily into the bloodstream. This process can be carried out for both hard and soft gelatin capsules, and it is administered less frequently than immediate-release dosages.

 

Enteric Capsules
Once a medication is administered orally, it can be easily broken down by stomach acids before it passes through the intestine and is distributed to the areas experiencing symptoms via the bloodstream. To prevent this absorption from happening in the stomach, enteric coating, which is used during oral delivery of medicines, vitamins, and supplements, degrades quickly in the stomach, preventing the ingredients from being released until they get to the intestine.

 

Vegetarian Capsules
Unlike gel capsule types, which are made from animal bones, skin, and cartilage, vegetarian capsules or veggie caps are made up of cellulose-a complex polysaccharide that forms the principal component of the plant cell wall. Since these shells are made from vegetables, they are ideal for people who do not eat fish, meat, and other animal products.

 

Application of Capsule Shell
 

Drug Packaging

Various drugs that stimulate the stomach are inserted into capsules whose shell is mainly made of starch. Because starch cannot be absorbed in the stomach, the capsule carries the drug into the small intestine and is absorbed directly.

Health Care Product Packaging

The smell or taste of some health care ingredients may cause discomfort to the human body, and the use of suitable capsule shells for packaging can increase the compliance of the human body. The capsule shell can also provide protection for ingredients such as light protection.

 

How Do You Choose the Right Capsule Shell Material
Capsule Shell
Empty Capsule Shells
Empty Capsule Shell
Organic Capsule Shells

Limitations of Gelatin
Gelatin capsules typically contain 12-16% of moisture that is vital for its flexibility. Gelatin has plenty of amino, carboxyl and hydroxyl groups and therefore can easily absorb moisture. Any drastic variation from its stated moisture content deteriorates its quality. For example, low moisture levels can make the capsules brittle while too much of it can make them soggy and sticky. This renders them incompatible with hygroscopic or moisture-sensitive ingredients which may bring about alteration in their moisture content and adversely impact the therapeutic performance of the drug product.

 

Newer Alternatives
These shortcomings of gelatin have propelled the search for better and greener alternatives. Hydroxypropyl methylcellulose (HPMC), a cellulose based material is one such candidate seen as potential replacement for gelatin. HPMC, a water swellable polymer, commonly known as hypromellose is manufactured by modifying naturally obtained plant-based cellulose. HPMC capsules have high biodegradability, good film forming ability, high stability and are inert to many drug and excipients. Similarly, pullulan another alternative for capsule is a viscous polysaccharide which is obtained by α-1, 6-glycosidic linkages between maltotriose units.

 

Comparison of Physico-chemical Properties
The primary application of hard capsule lies in its ability to protect the content of capsules from outside environment. Hence, moisture-sorption and desorption properties of capsules are key parameters for capsule performance. And any change in moisture content may result in capsule brittleness or stickiness thereby affecting the crystallinity, stability or efficacy of the drugs inside them. Studies have shown that the hygroscopicity of HPMC is much lower than gelatin and pullulan capsules.

 

Dissolution
In vitro dissolution testing is an important parameter for predicting a product's efficacy. Gelatin and pullulan capsules show reliable dissolution. However, gelatin is incompatible with formulations containing aldehydic functional group; formaldehyde produced by Maillard reaction with lactose, forms an insoluble pellicle that retards dissolution. Environmental factors like UV light, high relative humidity (75%), temperature (>40°C) can also induce gelatin crosslinking. Gelatin crosslinking which occurs due to chemical reactions between the amino acids or peptide chains of gelatin can result in a slower release or no release of drug.

 

Process of Capsule Shell
 

Melting and Coloring Materials

For the capsule manufacturing process, melting and coloring the raw materials is the initial step. This involves heating hard gelatin in a melting tank until it forms a uniform solution. At this point, distilled water is combined with gelatin to make a smooth viscous liquid. Then, the gelatin solution is heated at a constant temperature until it dissolves completely without degrading its properties. After the gelatin melts, coloring agents are inserted to achieve the desired color for the hard capsules or softgel capsules.

Molding and Drying Capsules

Once a solution of gelatin is ready, capsules are molded and dried. To make the shells of the capsules, one can immerse stainless steel molding pins in a gelatin solution via the dipping process. Then, these pins that are coated with gelatin are rotated so as to obtain uniform coating and for the excess substances to be wiped out. Thus, this step is very crucial in ensuring uniformity of size and thickness of these capsules.

Cutting and Trimming Capsules

For every capsule to meet the required specifications, there are essential stages in a tablet manufacturing process that involve cutting and trimming. After gelatin has dried, hardened, and forms the capsule shells, they are cut and trimmed to their final dimensions using a pin plate. In this phase of production, accurate cutting tools are used to achieve clean, uniform edges. It is important that capsules fit properly together to prevent any leakage of drug content.

Inspecting Capsule Quality

Capsule manufacturing processes must undergo quality inspection. Capsules are directly visually inspected to check for any bubbles, dark spots, abnormal shapes, and irregularities, including black spots. Advanced capsule inspection machines and image processing technology are often used to improve the accuracy of this test, ensuring that only capsules with the highest possible quality proceed further.

Printing on Capsules

Printing colored capsules is essential when it comes to identifying and branding products. Specialized printing machines are used to print information on the capsules, such as the name of the drug, its dose, and details about its manufacturer. This stage helps distinguish between different drugs and ensures adherence to labeling guidelines.

Packaging and Storage

The final processes for capsule manufacturing include packaging and storage. After printing, the capsules are counted patiently and packed into appropriate containers like bottles or blister packs. The packaging has to protect the capsules against environmental conditions such as moisture and light that may lead to degradation of the medicine. Pharmaceutical packaging also encompasses labeling which contains vital details such as expiry dates and batch numbers.

 

How to Maintain Capsule Shell
 

Shielding from Adverse Conditions

First, choose a storage area carefully. Avoid direct sunlight, heat sources, or areas near pipes which could expose the capsules to adverse conditions. A cool, ventilated shelf provides ideal protection.

Sterilization Precautions

Promptly sterilize any containers that have been opened to prevent bacterial growth. Contamination can compromise quality and safety, so proper sterilization after opening reduces risk.

Temperature and Humidity

Control the environment's temperature and humidity. Around 15-25°C and 35-65% relative humidity is best. Too high or low of extremes can damage the capsules through softening, stickiness, breakage or brittleness.

 

 
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FAQ

 

Q: How long does it take for a capsule shell to dissolve?

A: Twenty to thirty minutes
A standard gelatin hard capsule dissolves in the stomach, under normal conditions, within twenty to thirty minutes after swallowing. Depending on the application, different gelatin types or additional process steps can influence the dissolution process.

Q: What are the conditions for capsule storage?

A: Correct storage and packaging are important to achieve maximum product shelf life and achieve target quality levels. As mentioned earlier, finished gelatine capsules have a 13% to 16% moisture content, so storing in the range of 35% to 65% relative humidity and 15 to 25°C (59 to 77°F) will maintain this.

Q: Can you just take the powder out of capsules?

A: Advice from the NHS is not to crush pills, open capsules or alter your medicine without getting medical advice as this could stop the medicine working properly. Tablets and capsules are very complex and specifically developed to treat the patient's condition.

Q: Does capsule cover dissolve in your stomach?

A: When the capsule is swallowed, the capsule shell first dissolves in the digestive tract, and then the quick-release pill starts to release the drug. The released drug is absorbed into the body by the gastrointestinal tract, and the drug concentration in the body gradually rises.

Q: Do capsules always dissolve?

A: For these coatings to dissolve, they must come in contact with the less acidic environment of the small intestine or with the digestive enzymes there. However, the coatings do not always dissolve as intended. The tablet or capsule may be passed intact in the feces, especially in older people.

Q: What size capsule is easy to swallow?

A: The most common shape is the 00 size, and they are still easy to swallow. At the same time, they have a fairly high capacity, which means you have to swallow fewer capsules at a time.

Q: What should the moisture content of empty capsule shell be between?

A: Stored between 35–65%RH and 15–25°C, the LOD of hard gelatin capsules will remain within the optimal range of the gelatin capsules of 13–16% of moisture (2).Capsule manufacturers have designed their capsules to allow for entrapped air to escape to reduce the internal air pressure and to prevent a "pop back" effect where the capsules come apart due to the pressure.

Q: Is it okay to open capsules and put in water?

A: Some hard gelatin capsules can be opened and their contents (powder or granules) mixed with water or administered with food. Some capsules may be too small to be easily manipulated and opened. Pull the two sides of the capsule apart and tip the contents into a medicine pot.

Q: Can I empty the contents of a capsule?

A: Tablets or capsules that can be crushed or emptied.For tablets – put the tablet in the tablet crusher and empty the crushed tablet back into the plastic cup. For capsules – hold the capsule over the plastic cup and gently pull the two halves apart so the contents fall into the plastic cup.

Q: What are capsule shells made of?

A: Capsules are made up of gelatin (hard or soft) and nongelatin shells generally derived from hydrolysis of collagen (acid, alkaline, enzymatic, or thermal hydrolysis) from animal origin or cellulose based. However, currently, an issue of vegetarian and nonvegetarian capsules is coming up.

Q: What is the plastic coating on capsules made of?

A: First of all it's not plastic. It may look like it but it is actually gelatin. Gelatin breaks down in your stomach and passes through your system like any other food. Unless you are allergic or sensitive to the ingredient used to make the capsules then they're not anymore dangerous than anything else you would eat.

Q: Will medication still work if you poop right after taking medication?

A: Your meds are mainly absorbed through your stomach into the bloodstream. This is usually in the first few hours after taking them. The time you go to the toilet does not affect this at all. The only exception might be if you are very ill and have severe diarrhoea.

Q: What are the side effects of capsule covers?

A: They are reported to cause indigestion, upset and bloated stomach, hypersensitivity, exposure to toxins leading to gastric problems, and their excessive consumption can also cause kidney and liver damage. The protein from gelatin cannot be used by the body due to its incomplete form.

Q: Can capsules go bad?

A: Solid dosage forms, such as tablets and capsules, appear to be the most stable dosage form past their expiration date. Drugs that exist in solution or as a reconstituted suspension, and that require refrigeration (such as amoxicillin suspension), may not have the required potency if used when outdated.

Q: What happens if you take the powder out of a capsule?

A: The clinical consequences for the patient of crushing tablets or opening capsules can be serious: alteration of the drug's absorption can result in sometimes fatal overdose, or conversely underdosing, rendering the treatment ineffective.

Q: Why can't I swallow capsules?

A: There are a few reasons why you may have difficulty with medication in the form of pills, tablets, or capsules: A dislike for pills. Problems with the mechanics of swallowing. A temporary condition that makes it hard to swallow, such as taking antibiotics or going through chemotherapy.

Q: Can I open a capsule pill and take it?

A: Capsules can't be crushed or chewed, but many can be opened up and sprinkled on soft food. Always check with your pharmacist before modifying your medication or mixing it with food or liquid.As long as the capsule was completely empty, there should be no problem. The only time there might be a problem is if you happen to be allergic to whichever kind of gelatin the capsule itself is made from.

Q: Are you supposed to swallow capsules whole?

A: Most capsules are intended to be swallowed whole so patients should be encouraged to trial the 'lean-forward' technique. If swallowing difficulties remain other options, such as a liquid or tablet form of the medicine, can be considered.

Q: What humidity level should capsule be stored?

A: 35% to 65% relative
Correct storage and packaging are important to achieve maximum product shelf life and achieve target quality levels. As mentioned earlier, finished gelatine capsules have a 13% to 16% moisture content, so storing in the range of 35% to 65% relative humidity and 15 to 25°C (59 to 77°F) will maintain this.

Q: Do capsules disintegrate?

A: For immediate-release capsules, the gelatin shell disintegrates quickly in the acidic environment of the stomach. However, enteric-coated capsules are designed to resist the stomach's acidity and dissolve later in the intestines.

 

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