Category: Compounding Corner

May Compounding Corner – Indian Traditional Medicine

Let’s talk about one of the world’s oldest tradition of nature-based medicine!

Ayurveda originated in ancient India more than 5,000 years ago and still flourishes nowadays. It is believed that the Hindu God, Brahma, the creator of the universe passed on the holistic knowledge to the sages, who passed them on to the disciples and then to the common men orally and in writing. The name “Ayurveda” means “knowledge of life” and its practice is based on four eminent books of knowledge (Vedas) which describe operation procedures, medicinal plants and their healing properties.

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Similar to Chinese medicine, Ayurveda believes that the entire universe is composed of five elements: Vayu (Air), Jala (Water), Aakash (Space or ether), Prithvi (Earth) and Teja (Fire). These five elements form three vital forces or Tridoshas (Vata, Pitta, Kapha) that control the basic physiological functions of the body. Ayurveda adopts a holistic approach towards healthcare and its goal is to achieve optimal health, prevent diseases and treat on all levels of the human body: physical, psychological, and spiritual. Ayurveda relies a lot on treatments based on herbs and plants, special diets, food, oils (such as sesame oil), common spices (such as turmeric), and other naturally occurring substances such as minerals and animal based products.

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In India, about 15,000 medicinal plants have been recorded, in which the communities used 7,000-7,500 plants for curing different diseases. The medicinal plants can be used as single or multiple herbs (polyherbal) treatment. Basically, the phytochemical constituent in the herbals, such as saponins, tannins, alkaloids, alkenyl phenols, flavonoids, terpenoids, phorbol esters and sesquiterpenes lactones lead to the desired healing effect. A single herb may contain more than one phytochemical constituents, and the multiple constituents can work synergistically with each other in producing pharmacological action. Combining multiple herbs in a particular ratio would give a better therapeutic effect and reduce the toxicity.

In Ayurvedic preparations, the “herbal drug” or part/parts of a plant is chosen (leaves, flowers, seeds roots, barks, stems and etc.). Each and every part of the plants are fully used for preparing medicines depending on where its medicinal value lies and its curative effects on the body.

Probably until the 19th century, Ayurvedic medicines were prepared by practitioners at their homes using traditional tools and principles. This practice still continues for very specialized preparations passed down. In the 21st century, Ayurvedic herbal preparations are industrialized with modern processing methods in order to meet the growing demand for herbal products and convenient dosage forms.

 

 

Most of the active components of any herbs are water soluble in nature. The knowledge on the method of isolation, purification and characterization of active ingredients helped in improving the process of herbal preparations. There are two major types of processes in Ayurvedic medicine preparations, namely extraction, and separation. Extraction uses membrane rupturing and solute diffusion principles, while separation uses volatility, adsorption, and size-exclusion principles.

Source: Jain et al. 2014

 

As we see, Ayurvedas’ medicinal system has a rich history and continues to be practiced. Indian traditional medicine, particularly herbal medicine plays an important role for modern drug discovery and research with studies acknowledging the importance of such medicine and also showing correlation between the use of Ayurvedic herbs for particular symptoms and known pharmacological targets.

To know more:

  • Jain R, Venkatasubramanian P. Proposed correlation of modern processing principles for Ayurvedic herbal drug manufacturing: A systematic review. Ancient Science of Life. 2014;34(1):8-15. doi:10.4103/0257-7941.150768.
  • Parasuraman S, Thing GS, Dhanaraj SA. Polyherbal formulation: Concept of ayurveda. Pharmacognosy Reviews. 2014;8(16):73-80. doi:10.4103/0973-7847.134229.
  • Jaiswal YS, Williams LL. A glimpse of Ayurveda – The forgotten history and principles of Indian traditional medicine. Journal of Traditional and Complementary Medicine. 2014; 7(1):50-53. https://doi.org/10.1016/j.jtcme.2016.02.002.
  • Dash, Bhagwan & Junius, Manfred M (1983). A hand book of Ayurveda. Concept Pub. Co, New Delhi
  • http://somatheeram.in/Ayurveda/medicine-preparation
  • Preetam S, Kumar DH L, Dhumal C et al. Traditional and ayurvedic foods of Indian origin. Journal of Ethnic Foods. 2015, 2(3):97-109
  • https://nccih.nih.gov/health/ayurveda/introduction.htm
  • http://www.reagansrx.com/ns/DisplayMonograph.asp?StoreID=7a1b7cf76b654c2ba25baf9cdc754619&DocID=bottomline-ayurveda

Preparation of Suppositories

Compounding Corner – April 2017

You receive the following prescription in your pharmacy:


Patient: Jimmy R.

Age: 5

Sex: M

Prescription: 12 Glycerin suppositories using the following formula:

Glycerin Suppositories      (105 g)

Glycerin                                   91 g

Sodium stearate                  9 g

Purified water                      5 g

Directions: Insert ONE suppository into the rectum when required.


Questions:

  1. What is the use of this product?
  2. Explain the role of the components in this preparation.
  3. In compounding this prescription, you calculate for two extra suppositories to account for unavoidable loss in compounding. Calculations are therefore based on the amounts required to prepare 14 suppositories. What is the mass of glycerin-sodium stearate base that would be needed to prepare 14 child-size (2 g suppositories)?
  4. What size of suppository mold would you have used for an infant? For an adult?
  5. How many grams of sodium stearate are required to fill the prescription?
  6. What is the use of sodium stearate in this preparation?
  7. What is the volume of purified water required?
  8. What precautions should be taken when choosing the container of the suppositories?
  9. What are the labelling considerations for this preparation?

 

Indications for question 3: The glycerin-sodium stearate base has a density of 1.25. To correctly calculate the quantities required, the amount that would be required to fill the nominal weight will need to be multiplied by a factor of 1.25.

“View More” to reveal the answers to this month’s compounding corner!

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Answers:

  1. This product is used to treat constipation.
  2. Glycerin, a hygroscopic material, contributes to the laxative effect of the suppository by drawing water from the intestine and also from its irritant action on the mucous lining. The sodium stearate, a soap, is the solidifying agent in the suppository and may also contribute to the laxative action.
  3. A 1 g mold is usually used for an infant’s suppository, and a 4 g mold for an adult’s suppository.
  4. 14*2*1.25 = 35 g, total weight of mixture
  5. 91 (g)/105 (g) = x (g)/35 (g) ==> x= 30.3 g of glycerin
  6. 9 (g)/105 (g) = x (g)/35 (g) ==> x= 3 g of sodium stearate
  7. 5 (g)/105 (g) = x (g)/35 (g) ==> x= 1.7 g of purified water, which corresponds to 1.7 mL.
  8. The glycerin suppositories have the disadvantage of being very hygroscopic, therefore they must be protected from atmosphere and wrapped in waxed paper or tin foil. The suppositories could also be made in a disposable mold.
  9. The product name and list of the ingredients and their quantities.

The size of the suppositories (2 g) could be added as suppositories can be available in different sizes.

Product-specific cautions: ‘For rectal use only’ will need to be added to the label as the products are suppositories for rectal use; ‘Keep out of the reach of children’

Directions to patient:’ Insert ONE suppository into the rectum when required.’

Expiration date: 3 months.

 

February Compounding Corner Answers

Were you able to correctly answer the questions to the February Compounding Corner?

  1.   A solution is a liquid preparation that contains one or more active ingredients dissolved in a suitable vehicle. In contrast to a solution, a suspension is defined as a preparation where at least one of the active ingredients is suspended throughout the vehicle (not dissolved in the vehicle) and so the preparation will require shaking before a dose is administered.
  2.   Alcohol 90% v/v is used as the solvent of salicylic acid in this preparation.
  3.   This is an unofficial formula. We have to check that all the ingredients are within a safe dosage limit and are compatible.
  4.   1g of salicylic acid dissolves in 2.2 ml of alcohol 90% v/v 8g of salicylic acid dissolves in 2.2*8=17.6 ml *0.83=14.60g of alcohol 90% v/v
  5.   V=m/µ then 50g/0.89g/ml= around 56 mL so we will use a bottle of 60ml.
  6.   Salicylic and lactic acids are keratolytics. They work by breaking down the thick top layer of skin and increasing the amount of moisture in the skin. Salicylic acid causes the wart, corn, or callus to gradually peel off.
  7.   Flexible collodion works by forming a protective coating over the treated area. It helps to keep the area clean and also keeps the salicylic acid and moisture in contact with the skin.
  8.   Alcohol 90% v/v is a colorless liquid with a characteristic odor and taste.
  9.   An excipient is a substance formulated alongside the active ingredient of a medication. It is included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients (e.g.: bulking agents, fillers, diluents), or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility. However, excipients are not intended to exert therapeutic effects at the intended dosage.
  10. The product name and list of the ingredients and their quantities,
    • Product-specific cautions : ‘For external use only’ will need to be added to the label as the product is a solution for external use ; ‘Keep out of the reach of children’ ; ‘Caution: Flammable and volatile solution’
    • Directions to patient: ‘Apply as directed’
    • Expiration date: It is suggested to apply a 4-week discard date as the solution contains ethanol.

February Compounding Corner

Compounding Corner – February 2017
Preparation of a Magistral Formulation

You receive a prescription in your pharmacy with the following details:

_________________________________
Patient’s name : Rose D
Age : 50
Sex: F

Prescription: External solution

Direction: Apply on the wart
Salicylic acid 8g
Lactic acid 8g
Alcohol 90% v/v qs dissolve
Collodion to 50g

__________________________________

Questions

1. What is the difference between a solution and a suspension?
2. What is the use of alcohol 90% v/v in this formulation?
3. You are asked to prepare this external solution. What should you check first?
4. How much alcohol 90% v/v (in grams) would be required to produce the 50g solution?
5. You have bottles of 30 ml, 60 ml, and 90 ml available in your pharmacy. Which size of bottle are you going to use and explain your choice?
6. Salicylic and lactic acids are active ingredients. What are their properties on the skin?
7. What is the use of collodion in this preparation?
8. Indicate two organoleptic properties of alcohol 90% v/v.
9. Alcohol is an excipient. Give the definition of an excipient.
10. What are the labelling considerations for this preparation?

 

Here are some indications to answer the questions:

– one gram of salicylic acid is dissolved in 2.2 mL of alcohol 90% v/v
– density of the solution: 0.89 g/ml
– density of alcohol 90% v/v: 0.83 g/ml
– note: density=mass/volume

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