Composition of a pharmaceutical suspension Types of preservatives that might be used in suspensions - Alcohol 5-10% - Benzoates 0.1-0.3% - Parabens 0.02-0.2% - Phenols 0.2-0.5% - Quats 1:10,000- 1:50,000 - … 2. Ingredients can also be co-screened or co-milled to ensure their thorough mixing. Suspensions are typically manufactured using a high-energy mill to disperse the insoluble powder ingredients in the suspension vehicle. Chaudhari, S. and Patil, P. (2012). A knowledge of stability is essential by this stage, and conditions must have been developed to ensure that the drug is stable in the preparation. Suspension System Aniket … The internal phase consisting of insoluble solid particles having a … Fast dissolution is not always ideal. Chang, B.S. … Usually, such ingredients are premixed and/or adsorbed on the surface of another higher quantity ingredient before being mixed with the rest of the material. Journal of Pharmaceutical Sciences 90 (10), 1620-1627. Proteins have tertiary and quaternary structures that can be degraded or cause aggregation at room temperature. The solid ingredients are then added to this solution under high shear-mixing process in a sequential manner to form a suspension. Medical definition of oral suspension: a suspension consisting of undissolved particles of one or more medicinal agents mixed with a liquid vehicle for oral administration. Simler, R., Walsh, G., Mattaliano, R.J., Guziewicz, N., and Perez-Ramirez, B. Most protein formulations are parenteral due to the fragile nature of the molecule which would be destroyed by enteric administration. Examples include glycerol, propyleneglycol etc. The major stability factors in pharmaceutical suspension include attributes such as particle size distribution, content uniformity, viscosity, drainability, resuspendability, dissolution rate, pH, and zeta potential. Before administration, a lyophilized drug is reconstituted as a liquid before being administered. Regulations, Guidelines and Clinical Trials, Excipients Used in the Formulation of Pharmaceutical Suspensions, Mechanisms Involved in the Mixing of Pharmaceutical Powders, Advantages and Disadvantages of Pharmaceutical Powders, List of Pharmaceutical Companies in Switzerland, Elixir for Sourcing of Candidates and Retaining Them, Procedures for registration of pharmacists in Nigeria, Common Prefixes, Roots and Suffixes in Medical Terminology, National Agency for Food & Drugs Admin & Control, Journal of Pharmaceutical Development and Industrial Pharmacy. A pharmaceutical suspension is a coarse dispersion of insoluble solid particles in a liquid medium. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. Pharmaceutical suspension 1. The drug (active substance) itself needs to be soluble in aqueous solution at a controlled rate. These include particle size, shape, charge, size distribution, residual moisture content, ï¬owability, compatibility, and any aggregation tendency. These may include lyophilized formulations which are easier to stabilize at room temperature. 3. Drugs that have very low solubility are usually formulated as suspensions. These typically consist of hand-filled capsules containing a small amount of the drug and a diluent. Mixing of low quantity ingredients, such as colorants, can be challenging. Carpenter and M.C. (2014). Â© 2020 Pharmapproach Limited. Many parenteral formulations are unstable at higher temperatures and require storage at refrigerated or sometimes frozen conditions. Because of their liquid character, suspensions represent an ideal dosage form for patients who have difficulty swallowing tablets or capsules. For example, slow dissolution rates can prolong the duration of action or avoid initial high plasma levels. A colloid mill is usually used for the manufacture of pilot and production scale manufacture of suspensions on a commercial scale. The suspension is dispensed into bottles using automated liquid dispensing machines. 1-25, Rationale Design of Stable Lyophilized Protein Formulations: Some Practical Advice, Carpenter et al, Pharmaceutical Research, Vol 14, No.8, 1977, osmotic controlled-release oral delivery system, "Doctor, why are you prescribing an ointment? Consideration has to be given to what is known as "drug loading" - the ratio of the active drug to the total contents of the dose. In a few instances, viscous nonaqueous solvents, such as propylene glycol and polyethylene glycols, are used as vehicles to impart stability to suspended drug particles. Suspensions possess certain advantages over other dosage forms. Capsules can be designed to remain intact for some hours after ingestion in order to delay absorption. Like capsules, tablets, and pills etc. Composition of a pharmaceutical suspension 34. Manning eds.) Your email address will not be published. Examples of flocculating agents used in pharmaceutical suspension (usually at concentrations 0.01 â 1.00 %) include sodium or potassium chloride, aluminum chloride, calcium salts, citrates, etc. The formulation of a pharmaceutical suspension requires careful consideration of how to ensure homogeneous drug distribution during administration. Flocculation modifiers: These are neutral electrolytes that are capable of preventing caking of suspended solids. Wetting agents/ surfactants: Wetting agents are used to improve the flow of the liquid vehicle across the particle surface, which in turn improves the homogeneity of distribution of the drug particles throughout the formulation. Kluwer Academic/Plenum publishers, New York, pp. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The most commonly used vehicle for the formulation of pharmaceutical suspensions is purified water. We “Uber Pharmaceuticals” have gained success in the market by manufacturing a remarkable gamut of Pharmaceuticals Syrup, Cough Syrup, Antacid Adsorbent Antiflatulent Gel, Pharmaceutical Suspension, Multivitamin Drops, etc. The powder properties of incoming raw materials are critical and closely controlled to assure the quality attributes of powder blend. Formulated drugs are stored in container closure systems for extended periods of time. The dosage should have a uniform appearance, with an acceptable taste, tablet hardness, and capsule disintegration. An aqueous suspension is a useful formulation system for administering an insoluble or poorly soluble drug. Another method by which sustained release is achieved is through an osmotic controlled-release oral delivery system, where the active compound is encased in a water-permeable membrane with a laser drilled hole at one end. By continuing to use this website you are giving consent to cookies being used. Maximizing Data Collection and Analysis During Preformulation of Biotherapeutic Proteins. A pharmaceutical suspension is a coarse dispersion in which insoluble particles, generally greater than 1 µm in diameter, are dispersed in a liquid medium, usually aqueous. Kulshreshtha A., Singh O. and Wall M. (2010). This dosage form is used for providing a liquid dosage form for insoluble drugs. The word was introduced in late Middle English, through Latin from Arabic al-ʾiksīr (الإكسير), which in turn is the Arabization of Greek xērion (ξήριον) "powder for drying wounds" (from ξηρός xēros "dry").. Types Non-medicated elixirs. 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