Structure-forming excipients

Indication Active ingredient Cream trade name Structure-forming excipients Preservative... 

Indication Active ingredient Trade name Structure-forming excipients... 

Change in a supplier of a structure forming excipient that is primarily a single chemical entity (purity 95%) or change in a supplier or technical grade of any other excipient. 

Change in supplier of a structure forming excipient not covered under level 1. 

Change in the technical grade of structure forming excipient. 

Structure Forming Excipient An excipient which participates in the formation of the structural matrix which gives an ointment, cream or gel etc., its semisolid character. Examples are gel fonning polymers, petrolatum, certain colloidal inorganic solids (e.g., bentonite), waxy solids (e.g., cetyl alcohol, stearic acid), and emulsifiers used in creams. 

Change of >5% and < = 10% of approved amount of an excipient with the total additive effect of all excipient changes < = 10% Change in supplier of a structure forming excipient (not covered under level 1)... 

Change in technical grade of a structure forming excipient Change in particle size distribution of the drug substance, if the drug is in suspension... 

Change in supplier or technical grade of any excipient other than a structure forming excipient... 

Fluid-State PC. This PC is extracted from soybean, and its molecule contains mainly unsaturated fatty acids. Its transition temperature is approximately 0°C, and it is referred to as the fluid-state PC. The PC molecule has structure-forming properties, and is therefore used as an excipient, both in drugs and in cosmetic preparations. In addition, it is used as an pharmacologically active drug substance in oral, systemic, and topical formulations. 

PHOSPHATIDYLCHOLINE AS AN ACTIVE DRUG SUBSTANCE AND AS A STRUCTURE-FORMING "INERT" EXCIPIENT... 

Neupogen), a four-helix bundle cytokine, is formulated at pH 4 but has been shown to maintain both thermal stability and tertiary structure at pH 2.60 In fact, the secondary structure of this molecule was shown to remain highly helical at pH 4 (Tm approximately 62°C) and 2 (Tm approximately 63°C) as compared to pH 7 (Tm approximately 55°C) where a less conformationally stable form was observed. In the same study, FTIR and CD data corroborated the tendency of the protein to unfold as measured by the loss of helical structure in the order pH 7 > pH 4 > pH 2. Moreover, after determining optimal pH conditions of thermostability, several studies have shown that excipient screening at such conditions can successfully predict the rank of formulation cocktails that offer the most favorable stability.14 23 31 56... 

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