Aim– to prepare and submit the elixir
BACKGROUND
Elixirs are clear, sweetened, and pleasantly flavored oral liquid preparation, elixirs usually contain a high proportion of sugars or polyhydric alcohols such as sorbitol, propylene glycol, glycerine, and alcohol such as ethanol, which might be concentrated (95%) or diluted. 1,2 Additionally, the final formulation may contain syrup, flavoring agents, and preservatives. Moreover, due to ethanol and low sugar content, it is less viscous compared to simple syrup.2
Usually, this formulation contains one or more active drug, solvent is often used for increasing the solubility of these drugs when drugs have been used in elixirs it is indicated as medicated elixirs.2 for instance, cloxacillin elixir, pediatric digoxin elixir, and ephedrine elixir.1
Syrup and elixirs might appear confusing sometimes concerning the presence of alcohol in the syrup, for instance, ephedrine sulfate elixir USP contains 20-40 ml of alcohol in 1000 ml of water. The definitions are not that much important sometimes. Moreover, the alcohol content of the elixir may vary from low (3-5%) to 21-23% in different formations.
For instance, aromatic elixir USP contains 21-23% alcohol and ephedrine elixir IP, compound Benzaldehyde elixir USP contains 3-5% alcohol in it. Syrup and glycerine can be added to the elixir for many purposes such as, to increase the solubility of the drug/active ingredient, for sweetening purposes, propylene glycol can be added to some elixirs to substitute alcohol and glycerine.2 If the taste of the formulation is considered the syrup can be added to the formulation to improve the taste.
However, sucrose increases the viscosity and might decreases the solubility of the drug/active ingredient, it should be added after the dissolution of the drug/active ingredient. Furthermore, the final formulation of the elixir should be always clear, therefore, the filtration step can be added to remove particles in the elixir or purified by adding talc or siliceous earth.
In the last couple of decades, dry elixirs have been prepared by many researchers to increase the bioavailability of the drug/active ingredient, for instance, researchers have formulated ketoprofen dry elixir by spray drying method, they dissolved the ingredient including ketoprofen in alcohol; water (20;25 w/w) mixture in spray dried to form the dry elixir, additionally, they found the improved dissolution properties of dry elixir compared to the power alone.4
In recent years Ayurvedic elixirs have been prepared by some researchers, for instance, researchers have prepared Sidhhalepa Ayur Elixir 14 blood purifier from Azadirachta Indica. This preparation contains self-generated alcohol by fermentation (8.3 w/w%).5
REQUIREMENTS
Apparatus:
Beaker, Stirrer/glass rod, Measuring cylinder, spatula.
Chemicals:
Paracetamol, Paracetamol, Sucrose, Propylene glycol, Conc. mixed fruit juice, Chloroform spirit, purified water, color, Glycerine Q.S.
Formulation Table:
| Sr. No | Name of Ingredient | Quantity | Role |
| 1 | Paracetamol | 2.5 gm | Drug/ active ingredient |
| 2 | Paracetamol | 10 ml | Solvent (antimicrobial preservative |
| 3 | Propylene glycol | 10 ml | Flavor |
| 4 | Conc. mixed fruit juice | 2.5 ml | Flavor |
| 5 | Chloroform spirit | 2 ml | Preservative |
| 6 | Sucrose syrup | 28 ml | Sweetener |
| 7 | color | 0.0034 % | colourant |
| 8 | Glycerine Q.S | Up to 100 ml | Viscosity modifier |
PROCEDURE
It is simple to prepare, and the following procedure is followed for the preparation of elixir containing water and alcohol soluble substances. All water-soluble substances should be added to water and allowed to dissolve followed by the addition of sucrose and dissolve it.
Then all the alcohol soluble substances should be added to the alcohol and allowed to dissolve. Then both the solutions are added to make a single solution. The final concentration should be made up of purified water, a solution is filtered to make it clear, additionally, talc or siliceous earth can be used to make the elixir clear.3
- Wight the accurate amount of paracetamol and dissolve it in the measured quantity of alcohol and propylene glycol.
- Add the chloroform spirit, fruit juice, and syrup to the above solution with stirring
- Transfer the above resulting solution to the measuring cylinder and make up the final volume of elixir with purified glycerine.
- Filter the elixir to make it clear.
Evaluation – elixirs can be evaluated by visual inspection, clarity, odor, pH, and UV-Spectroscopy
Note- Most of the elixir’s formulations should be clear in appearance.
CONCLUSION
Paracetamol elixir is prepared and submitted.
[ps2id id=’references’ target=”/][ps2id id=’1′ target=”/]
REFERENCES
- Indian pharmacopoeia, 2018.
- Felton L. Remington: Essential of Pharmaceutics, am, J Pharm Educ. 2013.
- Tirunagari M, et al. Formulation and Evaluation of Pediatric Paracetamol Elixir Using Natural Colorant. Int J PharmTech Res. 2020;13(3):180-5.
- Ahn HJ, Kim KM, Kim CK. Enhancement of bioavailability of ketoprofen using dry elixir as a novel dosage form. Drug Dev Ind Pharm. 1998;24(7):697-701.
- Sylvester Darvin S, et al. Preparation and Standardization of Siddhalepa Ayur Elixir 14 Blood Purifier (Nimba arishta), A Traditional Ayurvedic Formulation. Acta Sci Pharma Sci. 2019;3(12):47-51.
FAQs
- What is an elixir?
ANS- Elixirs are clear, sweetened, and pleasantly flavored liquid preparation intended as an oral dosage form
- How the elixirs are different from syrups?
ANS- Elixirs have low viscosity and low concentration of sucrose in them, additionally elixirs contain alcohols in them, however, some syrups also contain alcohol is exceptional. Moreover in elixirs preservatives are added, and ethanol may act as an antimicrobial agent, in contrast, the syrup has its preservative effect due to osmotic pressure created by a high concentration of sucrose.
Recent articles: Preparation of simple syrup
Labmonk Blogs: Click here to visit.
Labmonk Notice Board: Click here to visit.
