Tammy Mathis05.01.02
The history of the capsule dates back to 1730 when it was first mentioned in a pharmacist's travel journal. Since then the evolvement of the dosage form has continued over the centuries facing several issues and overcoming many challenges. In 1931 Arthur Colton made a major breakthrough when he successfully designed a machine that would form and fit together a two-piece capsule on behalf of Park, Davis and Co. Even today's machinery holds the same basic design of Mr. Colton's original model.
The capsule as a dosage form has strong roots and continues to thrive as it provides a natural choice for dosage form decision makers.
The evolution of the capsule continues as the years have spawned a plethora of options. Sizes, colors and print designs offer a way in which companies can differentiate their products. Additionally, capsules are being developed with a variety of materials, which meet specific dietary requirements.
The are several capsule sizes to choose from including 000, 00, and 0, which are popular dietary supplement choices. Beyond these sizes, however, even smaller capsule options exist and include 1, 2, 3, and 4 (smallest).
A trend that is emerging in the nutraceuticals market is the use of color and print design to differentiate brands. There is an array of acceptable color choices available, including natural colorants. Print design really enables a product to have a visual impact on consumer recall of brands. Additionally, brand names, Internet addresses, logos or special designs are also used by manufacturers to further distinguish product lines.
Manufacturers are also becoming more sensitive to consumer needs by providing a wider selection of capsule choices that meet specific dietary requirements. Due to the global nature of the marketplace it has become increasingly important to understand the special needs of consumers. For example, the Halal two-piece capsules made by Capsugel meet the specific dietary needs of its Muslim customers and the capsules are certified as Halal by the Islamic Food and Nutrition Council of America (IFANCA). Further, capsules meeting Kosher needs are also available.
Another upward trend is the vegetarian capsule. As companies become more aware of filling specific dietary requests, many have reevaluated and revamped their product lines. Some companies are addressing the matter by adding line extensions and in some cases, they may choose to replace their gelatin capsule products with capsules made of vegetarian material. Although only a small portion of the population would consider themselves strict vegetarian-the larger population is becoming more in tuned to a vegetarian selection as this is a simple way to make a healthy lifestyle choice.
As in any manufacturing operation there are those problematic areas that beg for solutions. For encapsulation certain materials such as fruit and vegetable fibers and vitamin C can present challenges to operators of capsule filling machinery. These products are sticky and gummy and don't have the proper "flow characteristics" to provide good filling. Tim Sopko, technical service engineer for Capsugel, suggests adding colloidal silicon dioxide to improve the flow of the such gummy solutions, thereby improving overall production efficiencies.
Vegetarian and gelatin capsules pose another set of challenges. Vegetarian capsules and gelatin capsules look identical when unfilled as they have similar unfilled weight specifications and physical properties. However, when they are run on a filling machine, modifications should be made to accommodate gelatin or vegetarian material in order to optimize production. For instance, vegetarian capsules have much lower moisture content and are somewhat less resilient. Based on this difference, machine changes must be made to accommodate for moving from one material to the other. Both capsules will run well and give very positive results but it is important to remember that they are different and therefore require a different filling set up.
When there is a choice to be made between a compressed dosage form and a capsule-the capsule is a more natural choice because they require less excipients and binders. Moreover, the risk of over compressing a compound into a non-dissolvable mass is reduced. Whether the choice is a gelatin or non-gelatin, capsules offer the perfect container for pure formulations.
Capsugel has a history of experience with pharmaceutical companies and understands how to translate their learnings. Adopting practices from its pharmaceutical accounts, Capsugel coaches its customers in the practices that will ensure a positive encapsulation experience. As an example, customers are encouraged to regularly inspect for worn out parts, which can often be the root of poor machinability. They are also coached in adopting incoming controls, including the examination of the physical properties of raw materials, proper bulk densities and proper fill weights in finished products.
Capsugel also believes in partnering with its customer base. To support this, the company formed Capsugel University (CU). CU gives companies an opportunity to support quality, improvement and productivity through training and education. Its curriculum ranges from general courses such as capsule filling technology, good manufacturing practices (GMPs) and writing standard operating procedures (SOP's) to quality related courses such as statistical process control, data analysis and sampling. In addition to the overall curriculum offered at CU, courses can also be specially designed to meet the needs of its customer base.NW
About the author: Tammy Mathis is marketing specialist-dietary supplements for Capsugel, Greenwood, SC. She can be reached at 864-942-3830; E-mail: tammy.mathis@pfizer.com
The capsule as a dosage form has strong roots and continues to thrive as it provides a natural choice for dosage form decision makers.
Capsule Options
The evolution of the capsule continues as the years have spawned a plethora of options. Sizes, colors and print designs offer a way in which companies can differentiate their products. Additionally, capsules are being developed with a variety of materials, which meet specific dietary requirements.
The are several capsule sizes to choose from including 000, 00, and 0, which are popular dietary supplement choices. Beyond these sizes, however, even smaller capsule options exist and include 1, 2, 3, and 4 (smallest).
A trend that is emerging in the nutraceuticals market is the use of color and print design to differentiate brands. There is an array of acceptable color choices available, including natural colorants. Print design really enables a product to have a visual impact on consumer recall of brands. Additionally, brand names, Internet addresses, logos or special designs are also used by manufacturers to further distinguish product lines.
Manufacturers are also becoming more sensitive to consumer needs by providing a wider selection of capsule choices that meet specific dietary requirements. Due to the global nature of the marketplace it has become increasingly important to understand the special needs of consumers. For example, the Halal two-piece capsules made by Capsugel meet the specific dietary needs of its Muslim customers and the capsules are certified as Halal by the Islamic Food and Nutrition Council of America (IFANCA). Further, capsules meeting Kosher needs are also available.
Another upward trend is the vegetarian capsule. As companies become more aware of filling specific dietary requests, many have reevaluated and revamped their product lines. Some companies are addressing the matter by adding line extensions and in some cases, they may choose to replace their gelatin capsule products with capsules made of vegetarian material. Although only a small portion of the population would consider themselves strict vegetarian-the larger population is becoming more in tuned to a vegetarian selection as this is a simple way to make a healthy lifestyle choice.
Capsule Manufacturing Issues
As in any manufacturing operation there are those problematic areas that beg for solutions. For encapsulation certain materials such as fruit and vegetable fibers and vitamin C can present challenges to operators of capsule filling machinery. These products are sticky and gummy and don't have the proper "flow characteristics" to provide good filling. Tim Sopko, technical service engineer for Capsugel, suggests adding colloidal silicon dioxide to improve the flow of the such gummy solutions, thereby improving overall production efficiencies.
Vegetarian and gelatin capsules pose another set of challenges. Vegetarian capsules and gelatin capsules look identical when unfilled as they have similar unfilled weight specifications and physical properties. However, when they are run on a filling machine, modifications should be made to accommodate gelatin or vegetarian material in order to optimize production. For instance, vegetarian capsules have much lower moisture content and are somewhat less resilient. Based on this difference, machine changes must be made to accommodate for moving from one material to the other. Both capsules will run well and give very positive results but it is important to remember that they are different and therefore require a different filling set up.
When there is a choice to be made between a compressed dosage form and a capsule-the capsule is a more natural choice because they require less excipients and binders. Moreover, the risk of over compressing a compound into a non-dissolvable mass is reduced. Whether the choice is a gelatin or non-gelatin, capsules offer the perfect container for pure formulations.
Educational Initiatives:
A Case Study
Capsugel has a history of experience with pharmaceutical companies and understands how to translate their learnings. Adopting practices from its pharmaceutical accounts, Capsugel coaches its customers in the practices that will ensure a positive encapsulation experience. As an example, customers are encouraged to regularly inspect for worn out parts, which can often be the root of poor machinability. They are also coached in adopting incoming controls, including the examination of the physical properties of raw materials, proper bulk densities and proper fill weights in finished products.
Capsugel also believes in partnering with its customer base. To support this, the company formed Capsugel University (CU). CU gives companies an opportunity to support quality, improvement and productivity through training and education. Its curriculum ranges from general courses such as capsule filling technology, good manufacturing practices (GMPs) and writing standard operating procedures (SOP's) to quality related courses such as statistical process control, data analysis and sampling. In addition to the overall curriculum offered at CU, courses can also be specially designed to meet the needs of its customer base.NW
About the author: Tammy Mathis is marketing specialist-dietary supplements for Capsugel, Greenwood, SC. She can be reached at 864-942-3830; E-mail: tammy.mathis@pfizer.com
