Dina Mekhail

Gobiga Vanniyasingam

John Henen

Pharmaceutical Capsules

1. Introduction John (.5 min)

2. Results and Discussion 2.1 Properties of Powder Dina (2min)

2.2 Types of Capsules Gobiga (1min)

2.3 Hard Capsule Filling Gobiga & John (3 min)

2.4 Soft Shell Capsule Processes Gobiga (2min)

2.5 Advantage vs. Disadvantage of Capsules John (2 min)

2.6 Effects of Lubricants on Powder and Capsule Filling Properties Dina (2 min)

2.7 Challenges in Capsule Manufacturing John (.5 min)

3. Conclusion Gobiga (2min)

4. Reference

Contents

Introduction

• Capsules are:– Widely used– Cost efficient– Easy to manufacture

• Filling Machines efficiency depends on:– Physical properties– Flow properties

1. Introduction Slide#3

2. Results and Discussion 2.1 Properties of Powder

Slide#5

2.2 Types of Capsules Slide#7

2.3 Capsule Filling Slide#9-12

2.4 Soft Shell Capsule Processes Slide#14

2.5 Advantage vs. Disadvantage of Capsules Slide#16-17

2.6 Effects of Lubricants on Powder and Capsule Filling Properties Slide#19-21

2.7 Challenges in Capsule Manufacturing Slide#23

3. Conclusion Slide#25

4. Reference Slide#27

Contents

Definition: A pharmaceutical powder is a mixture of finely divided particle of drugs or excipients in dry form.

• Particle Size: Difference in size >> efficient packing via interlocking effects Particle Size Distribution (PSD) in a powder sample Affects powder bulk flow Small size particles Vs. large size particles

• Particle solubility Affects drugs disintegration and dissolving

• Particle Shape Isometric: round shape >> best for hard capsule Anisometric: needle-shaped >> different particle orientation >> irregular fluidity

• Particle Adhesion Dissimilar particles stick to one another to surfaces. Therefore, substances break powder uniformity

• Particle wettability Critical to drug substance release

• Flowability Ability of powder to flow in an equipment. Depends on physical properties of powder and the used equipment i.e. bulk density, friction permeability, forces, porosity.

Properties of Powder

1. Introduction Slide#3

2. Results and Discussion 2.1 Properties of Powder

Slide#5

2.2 Types of Capsules Slide#7

2.3 Capsule Filling Slide#9-12

2.4 Soft Shell Capsule Processes Slide#14

2.5 Advantage vs. Disadvantage of Capsules Slide#16-17

2.6 Effects of Lubricants on Powder and Capsule Filling Properties Slide#19-21

2.7 Challenges in Capsule Manufacturing Slide#23

3. Conclusion Slide#25

4. Reference Slide#27

Contents

Types of Capsules

1. Introduction Slide#3

2. Results and Discussion 2.1 Properties of Powder

Slide#5

2.2 Types of Capsules Slide#7

2.3 Capsule Filling Slide#9-12

2.4 Soft Shell Capsule Processes Slide#14

2.5 Advantage vs. Disadvantage of Capsules Slide#16-17

2.6 Effects of Lubricants on Powder and Capsule Filling Properties Slide#19-21

2.7 Challenges in Capsule Manufacturing Slide#23

3. Conclusion Slide#25

4. Reference Slide#27

Contents

• Tamp filling system into capsule size one

• Dosator nozzle system into capsule size zero

• Powder in dosator nozzle can be calculated

Hard Capsule filling

• Three different bed heights used

• Pin setting tested for each bed height and ranged from no compression to firm compression

Tamping filling machine

• Acceptable filling can be achieved and independent of type of machine

• Tamp filling better for coarser granules and no solid plug can be formed

• Dosator nozzle filling machine- plug formed but denser than maximum bulk density

Tamping filling machineCont’

Disadvantage: the large variety of possible machine settings.

Tamping filling machine

1. Introduction Slide#3

2. Results and Discussion 2.1 Properties of Powder

Slide#5

2.2 Types of Capsules Slide#7

2.3 Capsule Filling Slide#9-12

2.4 Soft Shell Capsule Processes Slide#14

2.5 Advantage vs. Disadvantage of Capsules Slide#16-17

2.6 Effects of Lubricants on Powder and Capsule Filling Properties Slide#19-21

2.7 Challenges in Capsule Manufacturing Slide#23

3. Conclusion Slide#25

4. Reference Slide#27

Contents

Accogel process- process for manufacturing of soft gels with powders or granules

Measuring roll rotate directly over the die roll and pockets in the 2 rolls are aligned Measuring roll powder or granular fill material under vacuum

Die roll plasticized sheet under vacuum

Sealing roll second gelatin sheet applied to form other half of capsulePressure developed between die roll and sealing roll seals and cuts out the capsules

Drying process

Capsule need to be dried hard for packaging. Tumble dryer used for soft capsule about 30 to 40 min remove 25%

transferred to drying room and it takes about 24-48 hours

Soft Shell Capsule Processes

http://kinam.com/Lectures/363/3.Capsules%20Text.pdf

1. Introduction Slide#3

2. Results and Discussion 2.1 Properties of Powder

Slide#5

2.2 Types of Capsules Slide#7

2.3 Capsule Filling Slide#9-12

2.4 Soft Shell Capsule Processes Slide#14

2.5 Advantage vs. Disadvantage of Capsules Slide#16-17

2.6 Effects of Lubricants on Powder and Capsule Filling Properties Slide#19-21

2.7 Challenges in Capsule Manufacturing Slide#23

3. Conclusion Slide#25

4. Reference Slide#27

Contents

Advantages

• Easy to swallow• Taken in various ways

such as oral, topical, and chewable

• Tamper-resistant

Disadvantages

• Stick together• Costly• Made out of the bones

and skins of pigs

Advantage vs. Disadvantage of CapsulesSoft Capsules

Advantages

• Rapid drug release• Come in different shapes

and sizes• Good oxygen barriers

Disadvantages

• Filling equipment is slower

• Stick together• Made out of the bones

and skins of pigs

Advantage vs. Disadvantage of CapsulesHard Capsules

1. Introduction Slide#3

2. Results and Discussion 2.1 Properties of Powder

Slide#5

2.2 Types of Capsules Slide#7

2.3 Capsule Filling Slide#9-12

2.4 Soft Shell Capsule Processes Slide#14

2.5 Advantage vs. Disadvantage of Capsules Slide#16-17

2.6 Effects of Lubricants on Powder and Capsule Filling Properties Slide#19-21

2.7 Challenges in Capsule Manufacturing Slide#23

3. Conclusion Slide#25

4. Reference Slide#27

Contents

Table 1: results from tap density and shear cell experiments.

Experimental Results

• Table 2: results obtained from capsule filling on the basis of flow (CTD = 0)

Experimental Results

• Table 3: Results obtained from capsule filling basis on compression (CTD = 18)

Effects of Lubricants on Powder and Capsule Filling Properties

1. Introduction Slide#3

2. Results and Discussion 2.1 Properties of Powder

Slide#5

2.2 Types of Capsules Slide#7

2.3 Capsule Filling Slide#9-12

2.4 Soft Shell Capsule Processes Slide#14

2.5 Advantage vs. Disadvantage of Capsules Slide#16-17

2.6 Effects of Lubricants on Powder and Capsule Filling Properties Slide#19-21

2.7 Challenges in Capsule Manufacturing Slide#23

3. Conclusion Slide#25

4. Reference Slide#27

Contents

• Weight Variations

• Friction Heat

• Bad Flow Properties

Challenges in Capsule Manufacturing

1. Introduction Slide#3

2. Results and Discussion 2.1 Properties of Powder

Slide#5

2.2 Types of Capsules Slide#7

2.3 Capsule Filling Slide#9-12

2.4 Soft Shell Capsule Processes Slide#14

2.5 Advantage vs. Disadvantage of Capsules Slide#16-17

2.6 Effects of Lubricants on Powder and Capsule Filling Properties Slide#19-21

2.7 Challenges in Capsule Manufacturing Slide#23

3. Conclusion Slide#25

4. Reference Slide#27

Contents

• Capsules- important deliver system• Possible Different mixture and ingredient • Hard gelatin capsules- oxygen barrier• Powder properties involve in production• Improve need in capsule filling machines• Low concentration lubricants- improve powder flow

ability • High concentration lubricants- machine performance

Conclusion

1. Introduction Slide#3

2. Results and Discussion 2.1 Properties of Powder

Slide#5

2.2 Types of Capsules Slide#7

2.3 Capsule Filling Slide#9-12

2.4 Soft Shell Capsule Processes Slide#14

2.5 Advantage vs. Disadvantage of Capsules Slide#16-17

2.6 Effects of Lubricants on Powder and Capsule Filling Properties Slide#19-21

2.7 Challenges in Capsule Manufacturing Slide#23

3. Conclusion Slide#25

4. Reference Slide#27

Contents

• Jenike and Johanson Inc. "Improving Powder Flow During Pharmaceutical Operations – Rx Times Pharmacy Magazine." Rx Times Pharmacy Magazine. 26 Oct. 2010. Web. 28 Jan. 2012. <http://www.rxtimes.com/improving powder-flow-during-pharmaceutical-operations/>.

• Hubbard, A. "Powder Sampling and Particle Size Determination, Terence Allen, Elsevier, Amsterdam, 2003, 660 Pp." Journal of Colloid and Interface Science 277.2 (2004): 505. Print.

• http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/152003/52997/article.pdf • Greb, Erik. "Consist Capule Filling." Pharmtech. 08 Feb. 2008. Web. 07 Feb. 2012.

<http://www.pharmtech.com/pharmtech/Article/Consistent-Capsule-Filling/ArticleStandard/Article/detail/492624>.

• Stegermann, Sven. "Hard Gelatin Capsules Today-Tomorrow." Capsugel Library, 2002. Web. 04 Apr. 2011. <http://www.capsugel.com/pdf/Hard_Gelatin_Capsules.pdf>.

• "The Hard Gelatin Capsule Advantage." Capsugel Library, 2002. May. 2011. <http://www.capsugel.com/media/library/the-hard-gelatin-capsule-advantage.pdf>.

• Irache, J.M. "Cápsulas / Capsules" Universidad de Navarra, Feb 15, 2012. <http://www.www.unav.es/farmytec/.../TF2-5-FF-ORAL-CAPSULAS-2008.pdf>.

• Podczeck, F. and J.M. Newton, Powder filling into hard gelatine capsules on a tamp filling machine. Int J Pharm, 1999. 185(2): p. 237-54.

• Podczeck, Fridrun, Simon , Blackwell, Matthew Gold, and J. Michael Newton. "The Filling of Granules into Hard Gelatine Capsules." International Journal of Pharmaceutics 59–69 188.1999 (1999). Science Direct. Web. 25 Feb. 2012.

• Pharmaland: Pharmaceutical Machine Manufacturer|Softgel Capsule Machine Equipment|Packaging Machinery. Web. 27 march. 2012. <http://www.pharmaland.ca/SoftGel_How-Manufactured.asp>.

Reference

Q&A