Role of plasticizer in membrane coated
Plasticizers have the ability to interact with polymer chains, and provide desired flexibility, shock resistance, and smoothness to resultant system. In addition to the plasticizing effect they also play an important role in modulating drug release profiles. Selection of a plasticizer is critical for the stability of dosage form, the processing
Plasticizer Excipients | American Pharmaceutical Review
Plasticizer Excipients Plasticizers are used mainly for oral solid dosage forms. Plasticizers are added to the polymers used as film forming agents in order to make the polymer pliable and soft, enhancing the flexibility and plasticity of the films.
Impact of formulation excipients on the thermal, mechanical
PEG 4000, the co-plasticizer, provided dispersion stability by yielding a dispersible sediment without aggregation at the elevated processing temperatures. Zeta potential measurements indicated sodium lauryl sulfate (SLS) could be used as a potential stabilizing agent at concentrations above its critical micelle concentration (CMC).
Stabilizer Excipients | American Pharmaceutical Review
Stabilizers are used to help the active pharmaceutical ingredient (API) maintain the desirable properties of the product until it is consumed by the patient. For example, gelling agents can stabilize liquid dosage forms, such as suspensions and emulsions. Your search returned 20 Excipient Search across 7 suppliers. Showing 20 of 20 products.
INTERNATIONAL JOURNAL PHARMACEUTICAL COMPOUNDING
237 Featured Excipient: Edetic Acid and Its Salts 240 Making Capsules Using a Solid Oral Dosage Form of a Different Strength Andrew Glasnapp, RPh; Yen-Tuyet-Hua 241 Calculations – Shelly J. Prince, PhD, RPh 242 Standard Operating Procedure for General Aseptic Procedures Used at a Laminar Airow Workbench PEER-REVIEWED STUDIES
- What is the purpose of an excipient stability study?
- The primary purpose of an excipient stability study is to provide evidence that the excipient will continue to meet manufacturer’s specifications, define recommended storage conditions in its sealed commercial packaging, determine shelf-life, and establish shelf-life claims.
- What is the stability of excipients?
- The stability of excipients varies. To foster communication between the excipient manufacturers and users, their stability may be described as falling into one of several broad classifications based upon the stability of the excipients in their commercial packaging.
- How many excipients are used in pharmaceutical products?
- In 1996, approximately 800 different excipients were used in marketed pharmaceutical products in the United States (De Jong, 1999). Excipient manufacturers usually supply their material to different end users, i.e. pharmaceuticals, food, and cosmetics.
- Do product safety data sheets reflect excipient stability studies?
- Note: Based upon industrial Enterprise Resource Planning (ERP) systems used, the product safety data sheet may not reflect the exact storage conditions from excipient stability studies. Where the stability study indicates conditions to avoid, these conditions should be specified on the label.
- What is excipient quality?
- Another, aspect of excipient quality has been introduced with the ICH Q8 (R2) guideline (ICH Q8 (R2), 2009), that described the identification of critical material attributes (CMAs) for the drug substance and excipients. Variations in excipient, e.g. particle size, have therefore become an integral part of the quality by design (QbD) principles.
- Do excipients influence the solubility and dissolution of pharmaceutical products?
- Paus et al. (2015) used this theoretical approach to study the influence of excipients on solubility and dissolution of pharmaceutical products. They measured the solubility of two model anionic APIs (naproxen and indomethacin) in the presence of polyethylene glycols (PEG), polyvinylpyrrolidone (PVP) and mannitol.
