Category: Compounding Corner (page 1 of 2)

July Compounding Corner – Aromatherapy

Aromatherapy

This month, let’s learn a little bit about aromatherapy. Aromatherapy refers to a range of traditional and alternative therapies that use essential oils and other aromatic plant compounds. Although essential oils have been used for centuries with the aim of improving a person’s health or mood, there is limited scientific evidence and little published research on many of them.

An essential oil is a concentrated liquid obtained from raw plant material, either by distillation with water and/or steam, from the epicarp of citrus fruits by a mechanical process, or by dry distillation.

 

Process of Extraction by Distillation:

Process of Extraction by Cold Pressing:

(Source: https://glorybee.com/process-of-essential-oil-extraction)

There are more than 400 essential oils, and each has a different chemical composition that affects how it smells, how it is absorbed, and its effects on us. Some of the more popular essential oils include lavender, peppermint, tea tree, eucalyptus, bergamot, rosemary, chamomile.

People who use aromatherapy believe some essential oils have beneficial properties. The theory is that aromatherapy can boost well-being, relieve stress, and help to refresh the body. Some essential oils are thought to have an anti-inflammatory effect, help to fight off infection, help with sleep disturbances, relieve anxiety, change your heart or breathing rate, or make you feel calm or excited.

The most common applications of aromatherapy include massage into the skin and inhalation of vapors. These methods allow the essential oil’s chemical compounds to cross into the bloodstream. However, users should be aware that these plant products are still chemicals, and they can be harmful if used in the wrong way.

The use of essential oils is rare in evidence-based medicine. Aromatherapy can likely help in minor ways; here are a few simple tips to follow and some aromatherapy remedies to prevent and ease your discomfort during holidays:

  • For example, if you’re anxious before flying on a plane, mix 3 drops of chamomile essential oil in 1 tablespoon of neutral oil and apply the blend on your solar plexus (or coeliac plexus, at the top of the stomach, in the middle of the abdomen) and wrists.
  • On a long and hot ride, you may start feeling ill. To relieve the feeling of nausea, put 2 drops of peppermint or ginger oil under the tongue. You can also put a few drops of either oil on a tissue and inhale the aroma at various intervals. Another method is to mix 3 drops of peppermint or ginger oil with 1 tablespoon of vegetable oil, and massage into your stomach area. If you do often get motion sickness, you should avoid sitting in the backseat, be sure to drink plenty of water, and eat a snack with some protein in it before departing.
  • You may be traveling to the other side of the world to meet your fellow pharmacy friends. Flying long can be quite tiring for your body. On long flights, get up and walk around as often as possible and do the exercises the airline often recommends. If you suffer from swollen ankles, this can be alleviated by massaging the blend of 5 drops of geranium essential oil with 1 tablespoon of vegetable oil into your ankles, feet, and calves before, during, and after the flight.
  • You should wear sunblock every time you go outside and reapply it every few hours, especially if you’ve just been swimming or doing physical activities causing you to sweat.  Sometimes, despite being careful, you still become overexposed, and the result is a painful sunburn. Here is what could do to relieve your pain — put in the palm of your hand: 1 tablespoon of jojoba or almond oil, 5 drops of lavender essential oil. Massage and apply gently this mixture on the affected area of your skin. Aloe Vera and cooled chamomile tea are known to be effective at helping to soothe and heal a burn. A cold shower can also help.
  • If you are traveling to an area where you will be affected by bothersome mosquitoes and flies, make the insect repellent blend below to take with you: 5 drops of citronella oil, 10 drops of lavender oil, 10 drops of peppermint oil, and 10 drops of thyme oil. When you are going out, mix 5 drops of this blend to 1 tablespoon of vegetable oil and massage this to exposed areas of your skin. If you’ve been bitten, put 1-2 drops of a mix of lavender and geranium oil on the bite.

We hope you now know more aromatherapy. Please keep in mind essential oils are very concentrated products and may be up to 70 – 80 times more potent in various chemical constituents than the dried herb itself. Essential oils have to be used safely and always diluted prior to applying them to the skin!

June Compounding Corner – Cremor leniens

Below is the formula of a softening cream called “Cremor leniens”:

White beeswax ………………………………………………….7.0 g

Cetyl palmitate ………………………………………………….9.0 g

Refined sunflower oil ………………………………………53.5 g

Virgin castor oil ………………………………………………….5.0 g

Glycerol monostearate 40-50 ………………………….5.5 g

Purified water …………………………………………………20.0 g

Methylparaben ……………………………………………….0.04 g

Propylparaben ………………………………………………..0.01 g

Propyl gallate ………………………………………………….0.02 g

Geranium essential oil ……………………………………0.3 ml

 

Questions:

  1. Creams are semisolid emulsions for topical use. How would you proceed when preparing this cream? Three methods of emulsion preparation are described below. Which one would you use in the case of Cremor leniens?
    • Methods of preparation of emulsions:
      • Wet gum method (English method): emulsion is formed by mixing the emulsifying agent with a dispersion medium in which it dissolves. This is then mixed with a dispersed phase.
      • Dry gum method (continental method): order of mixing is different; emulsion is formed by mixing the emulsifying agent with the dispersed phase in which it dissolves; and this is then mixed with the dispersion medium.
      • In situ soap method: emulsifying agent is produced during the preparation of emulsion (not added from outside).
  2. Emulsion are generally two-phase systems with an internal phase and an external phase such as oil-in-water (o/w) and water-in-oil (w/o). Emulsifier is used to maintain physical stability of emulsion. Please identify the emulsifier in the preparation of Cremor leniens and describe its mechanism of action. Based on the used emulsifier, which type of emulsion is it?
  3. Two more components can help maintain the physical stability. Their mechanism of action differs from the one employed by the emulsifier. Please indicate the general name of this kind of substances, their mechanism of stabilisation and identify them in the composition of the Cremor leniens.
  4. Which components are used to ensure microbial stability of the cream? Are there any antioxidants?
  5. In the formula of Cremor leniens, could the total amount of purified water and both parabens be replaced with the same amount of paraben preserved water (composition shown below)? Why? 
    • Paraben preserved water
    • Metylparaben                                  0.67 g
    • Propylaparaben                              0.33 g
    • Purified water               up to 1 000.0 g
  6. Two oils are used in the preparation. Which one is more hydrophilic and why?

 

   
Structure of major triglyceride present in castor oil
(source: wikipedia.org)
Structure of major triglyceride present in sunflower oil

(source: wikipedia.org)

7.    Contrary to Ungentum leniens (softening ointment), Cremor leniens does not have a cooling effect. Based on the composition of Ungentum leniens below, could you explain why it has a cooling effect after application on the skin?

Composition of Ungentum leniens : borax (sodium borate), white beeswax, cetyl palmitate, refined sunflower oil, virgin castor oil, geranium essential oil, purified water

 

Answers:

  1. The cream is prepared by wet gum method (English method) as the emulsifier is firstly dissolved in oil phase (the soluble phase).
    • A hot solution of parabens in water is prepared.
    • Beeswax, cetyl palmitate, both oils and glycerol monostearate are melted in the mortar. Propyl gallate is then dissolved in the melted mixture.
    • The solution of parabens is added to the melting step by step. The emulsified system is homogenised until cold.
    • The amount of evaporated water is used to adjust the weight of the cream.
    • Finally, geranium essential oil is added to the cool cream.
  2. Glycerol monostearate is an emulsifier. It acts on the interface by decreasing the interfacial tension. This cream is water-in-oil (W/O), it´s an hydrophobic cream.
  3. Besides emulsifier, quasi emulsifiers increases viscosity of the outer oil phase and thus helps to maintain the system stability. In Cremor leniens, these are white beeswax and cetyl palmitate.
  4. Both parabens are antimicrobial components and propyl gallate is an antioxidant.
  5. Parabens preserved water contains lower amount of parabens compared to what is required for compounding Cremor leniens. The increased amount of parabens is due to the fact that parabens are lipophilic substances and thus have some affinity to oil phase. Part of the entire amount can then pass to the oil phase. In order to ensure sufficient concentration of parabens in water phase, we should use the prescribed amount of parabens, not Parabens preserved water.
  6. Castor oil is more hydrophilic. Both oils are triglycerides, however, esterified with different fatty acids. Sunflower oil contains mainly triglycerides derived from linoleic and oleic acid. Castor oil has usually three ricinoleic fatty acids. Ricinoleic acid differs from other fatty acids because of hydroxyl functional group on C12 that increases its hydrophilicity.
  7. Ungentum leniens does not contain emulsifier, only two quasi emulsifiers, so the system is not stable enough. After application, the emulsified system disrupts and the released water has a cooling effect while evaporating.

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.

Image Source

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.

Image Source

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.

 

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