In addition, other factors that can be influential are the products might contain preservatives, so microorganisms cannot contaminate them Pramanick et al. Data analysis highlighted trends in the number of products approved, and the higher percentage of liquid parenteral protein formulations 66% compared to lyophilised formulations 34%. In addition, the paper highlights a need to better understand the impact of amorphous solutes on buffer crystallization and pH changes during lyophilization. Estimates on the prevalence of propylene glycol allergy range from 0. This starting material is usually reserved for industrial use because of the noticeable odor and taste that accompanies the final product. Excipients used in injectable formulation during pharmaceutical product development are the integral part to achieve desired product critical quality attributes.
Oftentimes, propylene glycol is combined with other mediations to enhance its penetration. Challenge is increased if the dose formulation is intended for intravenous i. Related to this application, propylene glycol reacts with propylene oxide to give oligomers and polymers that are used to produce. About the Author Carolyn Green has been a freelance writer since 1989. In order to reduce the size and maintain the size distribution of nanocrystals, surfactants are typically required to treat the surface of the nanocrystals, raising safety concerns due to the surfactant-induced side effects. Additional Uses The greatest amount of propylene glycol is found in the textile industry where it is used in polyester fiber production.
The moisture-induced solid-state aggregation has also been established and studied for three other lyophilized proteins: ovalbumin, glucose oxidase, and β-lactoglobulin. Phenytoin and Propylene Glycol Propylene glycol is a common diluent for injectable medications. The various initial formulations of the developed and those are examined for drug release profile, bioavailability, and clinical effectiveness and for the pilot plant studies and production scale-up. Ethylene glycol is metabolized in the liver to less toxic metabolites. Her passions include world travel, nutritional research and alternative medicine.
Propylene glycol is not metabolized to more toxic metabolites to the kidneys. Exposure to mists may cause eye irritation, as well as irritation. Propylene glycol is used as a E1520 , , and preservative in food and for tobacco products. It remains, however, unclear whether the increased persistence of the poly- sorbate 80-containing nanosuspensions is the cause or rather the consequence of the delay in the onset of the chronic inflam- matory phase and the diminished ability of the macrophages cf. Additionally, a decision making process for their incorporation into the formulation matrix has been proposed.
Ethanol therapy is unnecessary for patients having propylene glycol poisoning for which of the following reasons? Same might not be the same as the applied manufacturing process or different raw materials can have an effect on the excipient characteristics which is not reflected in the monograph testing. Functional uses of excipients include improving solubility and stability, safety and efficacy, as bulking agents in lyophilized formulations, tonicity agents, and aiding in controlled or prolonged drug delivery. Additionally, adverse health effects have been reported in the past due to toxic contaminations and product or process related impurities. A, January 23—26, 2001, page 21. Ethylene Glycol and Propylene Glycol Toxicity What is Propylene Glycol? There are many other food and industrial uses for propylene glycol. Compared with traditional carrier-based or encapsulation designs, drug nanocrystals circumvent possible side-effects due to carrier polymers and poor stability issues associated with encapsulation. The main excipients are therefore also to be found in the field of solid dosage formulation and nowadays often looked at as commodities by some parts of the industry.
The maximal degree of supersaturation is known as the metastable zone width. Pure optical isomers can be obtained by hydration of optically pure. The high concentration of propylene glycol contained in certain intravenous drug products, such as phenytoin, diazepam, digoxin, and etomidate, may induce thrombophlebitis. Brought to you by Medicinal Uses For medicinal purposes, propylene glycol is used as a solvent in different formats: injectable, oral and topical. Frozen solutions of citrate buffer have a low crystallization potential, relatively high collapse temperature, and minimal pH changes during freezing. The danger regarding the use of these falsified polypeptide drugs lies in the fact that end-users have no guarantee of the safety and efficacy of these preparations. It is used as stabilizer for vitamins, and as a water-miscible cosolvent.
Propylene glycol is used as which of the following in food products, cosmetics, and pharmaceutical products? Contact dermatitis has also occurred with topical application in the pediatric population. This concentration has been linked to use of water-based paints and water-based system cleansers. In addition, the number of products containing individual excipients, classified into functional categories is provided. The crystallized phases in frozen solution were identified by X-ray diffractometry. A model system has been elaborated and investigated to elucidate the mechanism of this phenomenon. Ethanol therapy does not help.
This comprehensive study showed that these type of falsified drugs not only have a high variation in amount of drugs per unit and a low purity ranging between 5% and 75% for cysteine containing peptides , but also contained the known toxic class one elemental impurities arsenic As and lead Pb. Excipients may demonstrate a synergistic effect when combined with an active ingredient but may also lead to unwanted reactions with the drugs and packaging components. John Wiley and Sons, Inc. Absorption of propylene glycol from the gastrointestinal tract is slow. Cases of hyperosmolality from absorption of creams applied to burns have been reported. Many more novel and increasingly complex excipients have been developed as novel drug formulation delivery systems emerge and evolve.
The of water is depressed when mixed with propylene glycol, owing to the effects of dissolution of a solute in a solvent. Crystalline nanoparticles are thermodynamically unstable colloid dispersion systems due to the large specific surface area and surface energy. Sources of Exposure In the general population, propylene glycol exposure occurs primarily through ingestion of food and medications and through dermal contact with cosmetics or topical medications. Propylene glycol is used in veterinary medicine as an oral treatment for in. In alcohol-based hand sanitizers, it is used as a humectant to prevent the skin from drying. Rapid infusion of solutions containing high concentrations of propylene glycol-containing drugs has been linked to respiratory depression, arrhythmias, hypotension, and seizures.
Vehicle toxicity and tolerability data are not readily available for a number of combination vehicles therefore, an i. For cosmetics and , the number is E490. However, limited human experience indicates that inhalation of propylene glycol mists could be irritating to some individuals. The compound is sometimes called alpha α-propylene glycol to distinguish it from the isomer , known as beta β-propylene glycol. Propylene glycol contains an asymmetrical , so it exists in two. This review article deals with proper selection of excipients in injectable drug products which gives stability physical and chemical , high critical temperature, good bulking properties avoiding melt back and collapse with improved dried product appearance.