Alginate capsules (hard and soft capsules)

3,255 views

Published on

Alginate capsules (hard and soft capsules), the technology that can replace gelatin capsules.

Published in: Technology, Business
1 Comment
0 Likes
Statistics
Notes
  • Be the first to like this

No Downloads
Views
Total views
3,255
On SlideShare
0
From Embeds
0
Number of Embeds
7
Actions
Shares
0
Downloads
57
Comments
1
Likes
0
Embeds 0
No embeds

No notes for slide

Alginate capsules (hard and soft capsules)

  1. 1. Alginate capsuleIntroduction: In the manufacture of pharmaceuticals, encapsulation refers to a range oftechniques used to enclose medicines in a relatively stable shell known as a capsule,allowing them to, for example, be taken orally or be used as suppositories. The twomain types of capsules are:Hard-shelled capsules, which are normally used for dry, powdered ingredients orminiature pellets (also called spheroids that are made by the process of Extrusion andSpheronization - Spheronization is a trade mark of Caleva Process Solutions) ortablets;Soft-shelled capsules, primarily used for oils and for active ingredients that aredissolved or suspended in oil. Alginate hard capsuleOverview: Novel hard capsules are made of alginate which is derives from marine algae. Itis safer for consumer (all ingredient of the capsule are non-animal based materials),more stable during shelf life (stable in boiling water) and cheaper than gelatincapsules. The alginate hard capsules can be designed for Active PharmaceuticalIngredient with gastric solubility, enteric solubility or colon solubility easily. Thealginate hard capsules are suitable for different kinds of API. Moreover, it can be usedin the field of food and industry due to its perfect safety, stability and low-costing.Photo of samples are showing below (upper side is gelatin shell, bottom side isalginate shell).
  2. 2. Specialty: ※Alginate, the major material of the shell, is extracted from algae which ischeap and used in food and drug for many years. It is full of human necessarymicroelement and used as health food in many countries. Moreover, alginate canabsorb heavy mental ion and free radical from human body with anti-cancer activity. ※ The capsule is very stable. There is no observable change on the shell ofcapsules after storage for three months under 50℃ and 80% RH. ※ The making process of alginate hard capsules is similar to gelatin hardcapsules. ※ The release of the API can be adjusted by different way which is suitable fordifferent API target to different location. ※ Alginate is chemical inert and can not react with the API in the corechemically or physically. ※ Alginates shell with little water content has antibiotic property which means itis no need or less need for preservatives. ※ All ingredient of the capsule are non-animal based materials which is suitablefor muslim and vegetarian consumer, and there is no danger from animal infectiousdisease. Alginate soft capsuleAppearance: Spherical, smooth and uniform with diameter of 1-10 mm (other shape and sizeother than above are available), oil based core (non-water soluble liquid) within thecapsule comprise at least 80% by weight of the capsule, shell of the capsule is alginategel. Diagram is showing below.A example of alginate capsules making process is showing below.
  3. 3. Samples picture (colored samples and non-colored samples) Handmade samples and dissected samples (suspension with high solid loading inthe capsules)
  4. 4. Overview: Patent (publication number: CN101564667, other patents will be published soon)of alginate soft capsules used novel material and novel technology. It is safer forconsumer (all ingredient of the capsule are non-animal based materials), more stableduring shelf life (stable in boiling water) and cheaper than gelatin soft capsules (costof the capsules is less than one third of gelatin soft capsules). Shell of the capsuleswill turn into alginic acid in stomach under the effect of gastric acid which can protectthe Active Pharmaceutical Ingredient in the core from decomposing by gastric acid. Inintestine, shell of the capsules will turn into soluble sodium alginate or potassiumalginate when meet with sodium or potassium ion then release the API in the core(another way of API releasing is that crosslinked alginate shell will de-crosslinked whenreact with bicarbonate excrete by pancreas or gallbladder). Detailed releasing profileis related with the shell thickness, alginate molecular weight and other facts. Thetechniques are suitable for different kinds of API soft capsule. Moreover, it can beused in the field of food and industry due to its perfect safety, stability andlow-costing.Specialty: ※Alginate, the major material of the shell, is extracted from algae which ischeap and used in food and drug for many years. It is full of human necessarymicroelement and used as health food in many countries. Moreover, alginate canabsorb heavy mental ion and free radical from human body with anti-cancer activity. ※ The capsule is very stable. A tested sample with volatile flavor dissolved inthe core maintains its flavor concentration after storage for one year and can be tastedits flavor after three years. There is no observable change on the capsules after storagefor three months under 50℃ and 80% RH. ※ Shell of the capsule comprise at most 15% by weight of the capsule whichcan improve the loading capacity of the API within the capsule.
  5. 5. ※ The making process of alginate capsules is similar to dripping pills whichhave applied in pharmaceutical industry for long time. It is very easy to producealginate capsules with different diameter just change the diameter of the dropper.Capsules with diameter less than 2mm, or even 0.5mm, can be made using a nozzleinstead of dropper. Capsules with diameter more than 7mm, or even 12mm, can bemade using a quantified pump instead of dropper. ※ The release of the API can be adjusted by different way which is suitable fordifferent API target to different location. The capsule is not soluble in stomach andwater which means it is suitable for non-acid-proof API or complex mixture API withhygroscopic ingredient. ※ Alginate is chemical inert and can not react with the API in the corechemically or physically. ※ Alginate capsules with suspension inside are easier to produce which has asolid content more than 80%. ※ Almost all API in powder (regardless of its particle size and solubility inwater/oil) can be encapsulated in alginate capsules. ※ Alginates shell with little water content has antibiotic property which means itis no need or less need for preservatives. ※ All ingredient of the capsule are non-animal based materials which is suitablefor muslim and vegetarian consumer, and there is no danger from animal infectiousdisease. ※ Due to its special thermal and humid stability, alginate capsules can be usedas novel product for soft capsules in the field of drug, food (especially for baked food),agriculture (especially for soft capsules for plant nutrition and animal food) andindustry (such as bacterium capsules for health food or water pollution treatmentusage). ※ There is no need for expensive equipment, organic solvent and toxic materialduring large-scale produce. The making-process is environment friendly and norubbish produced. There is no need for any equipment if daily yield less than 10million capsules. The cost of production line for more than 100 million capsules perday is less than 100,000 USD. Soft gelatin encapsulation machine with rotating mouldwhich is popular nowaday for soft capsules mass production can be applied foralginate capsules production with slightly adjustment. File update time: May. 2012 Contact me to: zhangwh_hn@hotmail.com

×