318 Pharmaceutical Dosage Forms Typical pharmaceutical carriers, nanosized active agents, and delivery systems include den-drimers and nanoparticles with functionalized surface, antibody–drug. Active Pharmaceutical Ingredient Natural Calcium Carbonate 2 Omya offers certified high purity, Natural Calcium Carbonate – a source of highly bioavailable calcium, specially designed for pharmaceutical applications. Omya Natural Calcium Carbonate is suitable for solid and liquid oral dosage forms in pharma applications. Tablet is defined as a compressed solid dosage form containing medicaments with or without excipients. According to the Indian Pharmacopoeia Pharmaceutical tablets are solid, flat or biconvex dishes, unit dosage form, prepared by compressing a drugs or a mixture of drugs, with or without diluents. They vary in shape and differ greatly in. Oral Dosage Forms: CONTD 18 Pills: 1. These are small, rounded solid dosage forms containing medicamentsintendedfororaluse. The medicaments are mixed with excipients to forms a firmsplasticmass. The mass is rolled to uniform pill pipe, which cut into numbersofuniformpills. Introduction to Pharmaceutical Dosage Form.pdf from JY 70 at University of Malaysia, Pahang. By Mohd Kaleemullah 1 Pharmaceutics: The study concerned with the formulation, manufacture.
Contents
Excipients used in the formulation of liquid dosage forms
Liquid dosage forms are prepared by combining drug substance(s) with different excipients. These excipients serve a variety of function in the liquid formulation; however, several excipients behave differently at different concentration and one excipient can be used for multiple purposes depending upon the need of the dosage form.
When formulating liquid medicines, it is essential to ensure that all the different excipient used is physically and chemically compatible with the drug substance and every other component of the formulation. Below is a list of common excipients generally used in the formulation of liquid dosage forms.
| Excipients | Role | Example(s) |
| Solvents/ vehicles | Liquid in which drugs and other excipients are dissolved or dispersed. | Purified water, alcohol, acetic acid, acetone, vegetable or mineral oils, organic oily bases, emulsified bases etc. |
| Co-solvents | Enhance solubility of drug substance in the vehicle | Ethanol. glycerol, propylene glycol etc |
| Surfactant | Enhance solubility of drug substance in the vehicle | Cetrimide, sodium lauryl sulphate, triethanolamine |
| Preservatives | Prevents microbial growth in the formulation | Parabens, phenylmercuric nitrate, sodium benzoate, benzalkonium chloride |
| Viscosity modifiers | Control the viscosity of the formulation | Cellulose polymers, polyvinyl pyrrolidone, alginic acid, xanthan gum |
| Buffers | Regulate the pH of the formulation | Phosphate buffers, Acetate buffers, Citric acid Phosphate buffers etc |
| Antioxidants | Control oxidation | Sodium bisulphite, ascorbic acid, butylated hydroxytoluene etc |
| Thickening agents. | Prevent settling/sedimentation, modify viscosity. | Methylcellulose, Hydroxyethylcellulose, Microcrystalline cellulose etc. |
| Chelating agents | Enhance stability of drug substance | Disodium edetate, phosphoric acid |
| Sweeteners | Enhance the palatability of oral liquid formulations | Sucrose, saccharin, aspartame, sorbitol |
| Flavouring agents | Enhance the palatability of oral liquid formulations | Lemon oil, orange oil, peppermint, menthol |
| Colourants | Enhance the aesthetic appearance of the formulation | Amaranth, Erythrosin, Eosin, Tartarazine etc. |
| Antifoaming agents | Discourage formation of stable foam | Simethicone, Organic phosphates, Alcohols, Paraffin oils, Sterates and glycols. |
| Humectants | Retard evaporation of aqueous vehicles from dosage forms | Propylene glycols, Glycerol, Polyethylene glycol etc. |
| Emulsifying agents | Prevent coalescence of the dispersed globules | Sodium Lauryl Sulphate, Cetrimide, Macrogol esters, Sorbitan esters etc. |
| Flocculating agents | Prevent caking | Starch, Sodium alginate, Carbomer.etc. |
| Excipient used in aerosol Propellant | Developing pressure in container which expels the product | Trichloromonofluoromethane, Dichlorodifluoromethane, etc. |
Manufacture of liquid dosage forms
Most liquid dosage forms are prepared:
- by simply dissolving the solutes (active pharmaceutical ingredient and excipients) in an aqueous or nonaqueous solvent or solvent mixture;
- by suspending the solutes in appropriate medium;
- by incorporating the solutes into an oil or water phase.
On an industrial scale, they are prepared in large mixing vessels with ports for mechanical stirrers. The vessels are generally thermostatically controlled to maintain a certain temperature if desired. The order of addition of components is fixed through product development and scale-up exercises.
Packaging of liquid dosage forms
Liquid dosage forms vary widely both physically and chemically, and in the ways they are distributed and used. Consequently, the materials from which the containers and packaging components are made also vary considerably and these containers are usually in direct contact with the formulation. For stability concerns, the container must not physically or chemically interact with the product so as to alter the strength, quality, or purity of the product beyond the official requirements.
Liquid dosage forms that contain light-sensitive active ingredients should be supplied in containers that are light resistant. If the preparation contains volatile ingredients, the liquid preparation should be kept in a tightly closed container. Except where indicated in the individual monograph, containers used in packaging liquid preparations for parenteral and oral use should be made from material that is sufficiently transparent to permit the visual inspection of the contents.
Labelling of liquid dosage forms
Every pharmaceutical preparation must comply with the labelling requirements established under Good Manufacturing Practice. The label should include:
1. The name of the pharmaceutical product
2. The name(s) of the active ingredients; International Nonproprietary Names (INNs) should be used wherever possible
3. The amount of active ingredient in a suitable dose-volume
4. The name and concentration of any antimicrobial preservative and the name of any other excipient
5. The batch (lot) number assigned by the manufacturer;
6. The expiry date and, when required, the date of manufacture;
7. Any special storage conditions or handling precautions that may be necessary
8. Directions for use, warnings, and precautions that may be necessary
9. The name and address of the manufacturer or the person responsible for placing the product on the market.
If the Liquid preparation is supplied as granules or powder to be constituted just before issue for use, the label should include:
- That the contents of the container are granules or powder for reconstitution
- The strength as the amount of the active ingredient in a suitable dose-volume of the constituted preparation
- The directions for preparing the liquid including the nature and quantity of liquid to be used
- The storage conditions and shelf-life of the constituted preparation.
Quality assurance and quality control/ Evaluation of liquid dosage form
Pharmaceutical Semisolid Dosage Forms Pdf
Like any other dosage form, liquid dosage forms have specifications for drug substance and drug products. To ascertain batch to batch uniformity and to ensure stability of the products over the recommended shelf life, manufacturers follow those specifications. An established and validated stability-indicating assay method is the key to quality control/quality assurance. Some of the parameters that are routinely monitored for liquid dosage forms are content uniformity, viscosity, pH, color, and odor. The efficacy of the preservative over the shelf life also should be monitored. For suspensions and emulsions, the effect of storage on flow properties and particle size also should be monitored.
References
- Ansel, H. (2010). Pharmaceutical Calculations, (13th ed.). London: Wolters Kluwer Health and Lippincott Williams & Wilkins.
- Chaudhari, S. and Patil, P. (2012). Pharmaceutical Excipients: A review. International Journal of Advances in Pharmacy, Biology and Chemistry, 1(1): 21-34.
- Denton, P. and Rostron, C (2013). Pharmaceutics: The Science of Medicine Design. United Kingdom: Oxford University Press.
- Gautami, J. (2016). Liquid Dosage Forms. Nano Science & Nano Technology, 10(3):1-9.
- Marriott, J., Wilson, K., Langley, C., and Belcher, D.(2010). Pharmaceutical Compounding and Dispensing (2nd ed.). UK: Pharmaceutical Press.
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