WHMF124 Session Three Pills Capsules

Transcription

1 WHMF124 Session Three Pills Capsules Endeavour College of Natural Health endeavour.edu.au 1

2 Session Three o o o o Understanding what is meant by Drug: Herb ratio Pills and tablets Advantages and disadvantages Commercial considerations Capsules Advantages and disadvantages Commercial considerations Make pills and capsules in tutorial Endeavour College of Natural Health endeavour.edu.au 2

3 Before we start o We should make sure that everyone is comfortable with the concept of the weight to volume ratio, aka the Drug Extract Ratio (DER) or the product ratio. o This is important for being able to compare doses and ensure proper dosing of patients. o The DER also expresses the weight of the original starting dried herbal material to the weight of the finished product Endeavour College of Natural Health endeavour.edu.au 3

4 Drug Extract Ratio For example, a dried herb equivalent of 1g could be: 1. 2mL of a 1:2 (1g:2mL Liquid Extract) 2. 1mL of a 1:1 (1g:1mL Liquid Extract) mg of 4:1 (1g:0.25g = 250mg Soft Extract) Endeavour College of Natural Health endeavour.edu.au 4

5 Drug Extract Ratio 4. 5mL of a 1:5 (1g:5mL tincture) mg of a 5:1 (1g:0.2g = 200mg spray dried herb) 6. 20mg of a 50:1 (i.e. 20mg x 50=1000mg dried herb) Standardised (Std) Extract Pro Extract powder this is the DER used for EGb 761 (Ginkgo biloba extract) Plant specimen taken by Johann Goethe ( ) of Ginkgo biloba Image credit: Wikipedia, viewed 10 January 2014, Endeavour College of Natural Health endeavour.edu.au 5

6 Drug Extract Ratio o Herbal medicines are expressed by their ratio of herbal material to solvent o Herbal material: solvent 1:2 = ½ strength 1:3 = 1/3 strength 1:1 = full strength 5:1 = 5 times the strength Endeavour College of Natural Health endeavour.edu.au 6

7 History of Pills and Capsules o It is not exactly known where the use of tablets as a hard dosage form originated from, albeit, it seems to come from both TCM and ancient Greek paradigms of medicine. o Powdered crude herb was literally bound with excipients such as honey, tragacanth or marshmallow to facilitate ease of shaping. Image credit: Wikipedia, viewed 10 January es_rubens.jpg Endeavour College of Natural Health endeavour.edu.au 7

8 History of Pills and Capsules o It became a very popular way to take medicines, obviously due to the lack of poor taste that is often associated with many of the various herbal liquid dosage forms... o A popularity that still exists today. o With the advent of tablet manufacture, so began the specialisation of herbal manufacturing, and thus, centuries of refinement later, the birth of pharmacy as we know it. Endeavour College of Natural Health endeavour.edu.au 8

9 Pills and Capsules o A Pill is an old term to describe a tablet. o It is a dosage form that incorporates the blending of various dry materials together and then moulding/compressing them into a solid form and shape conducive to swallowing. o Whilst it is comprised of the active ingredient, it also contains various excipients (non-active material). Image credit: Wikipedia, viewed 10 January 2014, Endeavour College of Natural Health endeavour.edu.au 9

10 Pills and Capsules Some examples of excipients are listed below: 1) Various coatings to aid stability (reduce uptake of moisture etc) 2) Various coatings to aid absorption (enteric coatings) 3) Binders (hold the ingredients in a tablet together, such as microcrystalline cellulose) 4) Anti-adherents (reduce the adhesion of the tablet powder to the punch moulds of a pharmaceutical press machie) AKA lubricants. Endeavour College of Natural Health endeavour.edu.au 10

11 Pills and Capsules 5) Disintegrants (cause the tablet to break apart when in the GIT to increase dissolution/ absorption) 6) Fillers or diluents (add bulk to a formulation, so it may meet the required size) 7) Flavours and colours (to appeal to various people, children etc) 8) Glidants (increase the flowability of the powder, especially in tablet machines) 9) Preservatives (to aid stability) Endeavour College of Natural Health endeavour.edu.au 11

12 Pills and Capsules - Advantages o They are a potent way of administering large doses of herbs, especially if extract pro extracts (high DER powders such as 50:1) are utilised o Are convenient and portable, whilst also storing well. o Bypass bitterness of other unpleasant tastes o Devoid of alcohol (< 3%), so appropriate where this solvent should be avoided. o Can be manipulated via various coatings to assist in absorption (i.e. enteric coating / delayed release) (Adams & Tan 2006, p. 24) Endeavour College of Natural Health endeavour.edu.au 12

13 Pills and Capsules - Disadvantages o o o o o o Loss of constituents due to processing, such as spray-drying, powdering etc. Not as easily or efficiently absorbed as Liquid dosage forms (currently a matter of vigorous debate) Excipients are ingested, which may prove detrimental (allergies etc) Relatively low dose (unless EPE s are used) Fixed formulation results in a lack of flexibility in prescribing for individual patients. Don t assist in treating localised problems, such as sore throats etc. (Adams & Tan 2006, p. 24) Endeavour College of Natural Health endeavour.edu.au 13

14 Tablet o Manufacturing techniques revolving around tablet manufacturing has changed somewhat over the years. o Tablet machines can now produce around 1 million tablets per shift, all of considerable similarity. In contrast, herbal tablets manufactured by hand cannot achieve such volume or consistency. Endeavour College of Natural Health endeavour.edu.au 14

15 Commercial Manufacturing As far as commercial manufacturing is concerned, according to GMP and QA procedures, tablets and capsules produced from specific machines and available for sale to the general public are required to conform to many different guidelines: 1. Friability: How tough the tablet is. It is put in a special machine that subjects the tablet to blunt gravity based impact. 2. Dissolution: Measuring the rate of drug release. Folate (B9) is a nutrient that requires dissolution testing to meet TGA requirements (Adams & Tan 2006, p. 24) Endeavour College of Natural Health endeavour.edu.au 15

16 Commercial Manufacturing 3. Disintegration: A tablet/capsule must disintegrate when placed in a 37.7 degree liquid agitator within a specified time limit. 4. Thickness and measurements are within specified limits 5. Tablet/capsule weight is within specified limits. 6. No metal filings are trapped in the tablet from machinery Endeavour College of Natural Health endeavour.edu.au 16

17 Capsules o There a 2 main types of capsule: 1) Soft (as seen in the picture) 2) Hard A common form of gelatine based capsule, which is a favourite dosage form for oil based preparations like fish and krill oil preparations. Image credit: Wikipedia, viewed 10 January Endeavour College of Natural Health endeavour.edu.au 17

18 Soft Capsules o One piece gelatinous capsule that is generally only able to be manufactured commercially, due mainly to the expensive and specialised equipment required. o The substance being encapsulated is generally liquid or semi-liquid, in contrast to the dry material used in hard capsules. o The shell of soft-caps are based mainly upon gelatine, glycerol and water. o The liquid active ingredients are generally suspended in a fill material that helps in stabilising the product, such as soya oil or Macrogol 400. (Adams & Tan 2006, p. 26) Endeavour College of Natural Health endeavour.edu.au 18

19 Hard Capsules o Hard capsules are generally two piece in manufacture and made from either gelatin or cellulose. The latter being known as a VegeCaps are good for people who dislike animal based gelatinous products. o Hard caps generally encapsulate dry powdered material. They are quite easy to manufacture at home, albeit can be quite time consuming. (Adams & Tan 2006, p. 26) Endeavour College of Natural Health endeavour.edu.au 19

20 Advantages o They are a potent way of administering large doses of herbs, especially if extract pro extracts (high DER powders such as 50:1) are utilised o Are convenient and portable, whilst also storing well. o Bypass bitterness of other unpleasant tastes o Devoid of alcohol, so appropriate where this solvent should be avoided. o Herbs such as capsicum or turmeric can be irritating to the mouth, so capsules and tablets are a good way of avoiding this occurring (Adams & Tan 2006, p. 24) Endeavour College of Natural Health endeavour.edu.au 20

21 Disadvantages o Loss of constituents due to processing, such as spray-drying, powdering etc. o Not as easily or efficiently absorbed as Liquid dosage forms o Excipients are ingested, which may prove detrimental (allergies etc) o Relatively low dose o Fixed formulation results in a lack of flexibility in prescribing for individual patients. o Don t assist in treating localised problems, such as sore throats etc. (Adams & Tan 2006, p. 24) Endeavour College of Natural Health endeavour.edu.au 21

22 Hard Capsule Formulation Ingredients: o Any dried herbal powder can be used Procedure: o o o Disinfect work area, equipment, hands Weigh out powder to get allocated dosage, use Mortar & pestle or an electric coffee grinder if required to grind into a finer powder. If you have a capsule making kit the process is simplified and it enables you to make 50 capsules within a short period of time (Adams & Tan 2006, p. 26) Endeavour College of Natural Health endeavour.edu.au 22

23 Hard Capsule Formulation For manual filling: o Place herbal powder into a bowl. Get comfortable. o Scoop up herb using a pharmacy palette, and pack (tamp) into the longer capsule end with a narrow chopstick o Close smaller end over larger end to seal the capsule o Place in an airtight container o Label and store correctly (Adams & Tan 2006, p. 26) o Please watch the video of making capsules o mp4?dl=0 Endeavour College of Natural Health endeavour.edu.au 23

24 Gentle Herbal Laxative Capsules Ingredients: o Glycyrrhiza glabra powder 10 grams o Taraxacum off. (radix) powder 10 grams o Juglans nigra powder 10 grams Method: o Blend the powders together thoroughly o Set up Cap-M-Quick system and follow instructions Dose: o 2-3 capsules 3 x daily o Use as required (Caution: Avoid during pregnancy and lactation) Endeavour College of Natural Health endeavour.edu.au 24

25 Using a Cap-M-Quick system 25 Endeavour College of Natural Health endeavour.edu.au 25

26 Traditional Pill Manufacturing 1) Prepare and disinfect all work areas and equipment. 2) Ensure the herb is suitably pure and powdered as appropriate. 3) Place the allocated amount of herbal material into a bowl and moisten with water or honey to form a sticky paste. 4) Thicken the mixture with Slippery Elm if required to form a smooth paste much like bread dough consistency. 5) Mould the tablets in balls or appropriate shapes. Coat with carob or slippery elm powder. 6) Dry in the sun or very low (Gas- pilot flame) oven for several hours. 7) Stored in an airtight container, they can last up to 12 months. Endeavour College of Natural Health endeavour.edu.au 26

27 Colic & Flatulent Pills Ingredients: o Cinnamomum verum powder o Elettaria cardomum powder o Foeniculum vulgare powder o Syzygium aromaticum powder o Zingiber officinale powder o Mentha piperita oleum o Honey, water and Slippery Elm to make paste 10g 10g 10g 1g 1g 1-2 drops (Adams & Tan 2006, p 24-25) Endeavour College of Natural Health endeavour.edu.au 27

28 Colic & Flatulent Pills Procedure: o Disinfect work area and equipment o Wash hands thoroughly consider wearing gloves as this can get messy o Weigh out ingredients o Place in large SS bowl and mix thoroughly (if mixer available, use this) o Add honey & water to form a sticky paste o Add Slippery elm powder and constantly mix and knead until the consistency of dough (bread). o Roll the mixture into tablet size shapes. o Coat in Carob/Slippery Elm. o Weigh, and dry in an oven. o Weigh again, then store in airtight container/label. (Adams & Tan 2006, p 24-25) Endeavour College of Natural Health endeavour.edu.au 28

29 PILLS No 1 (Traditional Rx) Ingredients o Lobelia seed (115g) o Cayenne (115g) o Valerian (115g) o Slippery elm (60g) o Dandelion extract (115g) Procedure o Mix and roll in slippery elm. o Designed to relax the system gradually, so as not to produce vomiting. o Useful in all cases of constriction or fever, head-ache, liver complaint. o DOSE: From one to four at night, or as often as the nature of the case may require. (A GUIDE TO HEALTH by Benjamin Colby Milford, N.H., 1846, Endeavour College of Natural Health endeavour.edu.au 29

30 Tasks: Tutorial Participation o Participation Forum participate with your comments every week o Answer the specific questions for each session on the LMS o Watch the videos (Links are provided on the slides) o Consistently work through your Study Guide each week o For procurement of herbs, please refer to resources on your LMS for the Herbal suppliers and manufacturing list. Click on the website links o If you have any questions for your tutor please contact them via the LMS. Endeavour College of Natural Health endeavour.edu.au 30

31 Tutorial Participation Optional Home-based Tasks: o Make the gentle laxative capsules (Slide 25) o Make colic and flatulence pills (Slide 27) Endeavour College of Natural Health endeavour.edu.au 31

32 Suggested Readings British Herbal Pharmacopoeia. (1996) British Herbal Medicine Association, Bristol. UK. Fenner, B. (1888) Fenner s Complete Formulary and Hand-Book (6 th ed.). Self published, New York. Retrieved on 20 February, 2017 from Green J. (2000). The herbal medicine-maker s handbook: A home manual. NY: Crossing Press. pp Endeavour College of Natural Health endeavour.edu.au 32

33 References o o Adams, J & Tan, E. (2006). Herbal manufacturing: How to make medicines from plants. Preston, VIC: Northern Melbourne Institute of TAFE,, Australia. pp Mills, S., & Bone, K. (2000). Principles and practice of phytotherapy, London, UK: Churchill Livingstone. Endeavour College of Natural Health endeavour.edu.au 33

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