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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.

 

AEFRA,ARGENTINA

 

Asociaón de Estudiantes de Farmacia  de la República Argentina

National EXco members:

President: Roberto Chaile.

Secretary General: Florencia Flores.

Treasurer: Franco Rizo.

Membership Secretary: Anahi Zanetti.

Communication Secretary: Bruno Da Passano.

Public Health Secretary: Federico Verona.

Academic and Pharmacy Education Secretary: Estefania Peralta Lopez.

Auditing Committee: Chair: Telma Acosta.

Substitute: Melissa del Rosario Tolava .

IPSF Contact Person: Cecilia Zuccarelli.

Student Exchange Officer: Damian Romero.

AEFRA (Argentine Republic Pharmacy Students’ Association) is a non-governmental organization for pharmacy students, founded in 2012 in San Luis. We are currently based all over the country, and we are dedicated to lead basic processes for the academic and professional development to all our members, through educational, social and cultural activities, seeking to benefit the national pharmaceutical community and the population in general.

We think AEFRA’s is one of a kind association. If you are wondering why, the answer is very simple: we, the Argentinian, are spontaneous, outgoing, supportive, and we have this unique feature – we always do whatever we really want (even if we don’t have the minimal idea of what we are doing!). This particular and rare feature, which sometimes is confused with stubbornness, always pushed us forward to face all the dreams and challenges along the way in our short life as an association. A convincing proof of this, is that we as a 4-year old association, organized 4 National Congresses, the 9th Pan American Regional Symposium, 3 AEFRA’s Solidary Programmes, the Students and Young Pharmacists’ Package for FIP World Congress 2016, and soon in 2018, we will be proud of hosting the 64th IPSF World Congress. In addition, we got the IPSF Full membership in 2015, and won several grants as the Best New Association in the world in 2015, Best Regional Association two years in a row (2015- 2016), and lastly Best Regional Contact Person and Best regional SEO in 2016. All of these achievements have been possible thanks to our strong will and sacrifice to move forward above all obstacles and always with the strongest passion and love for pharmacy that you will ever find in anyone. Therefore, if you meet an AEFRA member sometime, you will get to know a rare mixed of steel spirit, unbreakable will, giant heart and passionate pharmacy lover, with our most delighting feature – wherever we are, we are always going to bring joy and happiness to all our friends and partners. Wishful that one day you could visit us and know our wonderful country, we invite you to come to Mendoza in 2018 to taste the most delicious wine and beautiful landscapes. There you will learn about pharmacy innovation and enroll to the global improvement of pharmacy that IPSF and AEFRA both support since their creation.

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