Hypromellose is also referred to as HPMC for short. It is widely used in the field of food and medicine and is a commonly used pharmaceutical excipient.
The empty HPMC capsule is a product with a natural concept. Its material and production process are recognized by the Jewish, Islamic and Vegetarian Associations. It can meet the needs of people of various religions and eating habits and has a high acceptance. In addition, HPMC capsules also have the following unique properties:
The low water content makes the empty HPMC capsules suitable for filling hygroscopic or moisture-sensitive contents to extend the shelf life of the product. The water content of empty gelatin capsules is generally 12.5%-17.5%. The temperature and humidity of the environment should be controlled within an appropriate range during the production, transportation, use and storage of empty capsules. The proper temperature is 15-25°C and the relative humidity is 35%-65%, so that the product performance can be maintained for a long time. The water content of empty HPMC capsules is very low, generally 4%-5%, which is about 60% lower than that of empty gelatin capsules. Although the exchange of moisture with the environment during long-term storage will increase the moisture content of HPMC capsules in the specified packaging, it will not exceed 9% within 5 years.
As mentioned above, the gelatin film has a specified moisture content. If it is lower than this limit, the gelatin film will be significantly brittle. In contrast, the toughness of the empty HPMC capsule is much better, and it maintains good performance even if the ambient humidity is low.
When the gelatin capsule is placed in a high-humidity environment, the capsule shell will become soft, deformed, or even collapse after absorbing water. HPMC capsules can maintain good shape and performance even under high humidity conditions. Therefore, the empty HPMC capsules are highly adaptable to the environment. This advantage of empty HMPC capsules is particularly significant when the product sales area covers a variety of climatic zones or the storage conditions are relatively poor.
The cross-linking reaction of gelatin capsules is a thorny problem encountered in capsule formulations. Since the aldehyde group of the content reacts with the amino group of the amino acid in the gelatin to form a network structure, the capsule shell is difficult to dissolve under the conditions of in vitro dissolution, thereby affecting the release of the drug. Hypromellose is a cellulose derivative that is chemically inert and has excellent compatibility with most substances. Therefore, HPMC capsules have no risk of cross-linking reaction and have high chemical stability.
Enteric-coated capsules are used for drugs that are easily destroyed by gastric acid, are irritating to the gastric mucosa, or require targeted administration. The internationally accepted process for enteric-coated capsules is the overall coating of enteric-coated pellets and capsules. HPMC capsules show unique advantages in the overall coating of the capsules.
Studies have shown that, due to the rough surface of HPMC capsules, the affinity with most enteric coating materials is significantly higher than that of gelatin, and the adhesion speed and uniformity of the coating materials are significantly better than gelatin. Moreover, the permeability of the HPMC capsules in the stomach is lower after coating, and they have a good release in the intestinal tract.
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