What does the insulin glargine label say about formulation at pH 4 (excipients)?
Insulin glargine is formulated to be soluble at an acidic pH and then form a depot after injection, where it changes local pH and slows absorption. Many insulin glargine U-100 products use an acidic vehicle around pH 4 in the pre-injection formulation, and the package insert lists the specific excipients that make that pH and solubility possible.
To give you the exact “pH 4 formulation” excipients wording from the package insert, I need which exact product you mean (the excipient list can vary by manufacturer and presentation). The most common insulin glargine products people ask about are:
- Lantus (insulin glargine) injection
- Basaglar (insulin glargine) injection
- Semglee (insulin glargine-yfgn) injection
- Rezvoglar (insulin glargine-aglr) injection
If you tell me the brand name and whether it’s a vial, SoloStar/pen, or cartridge, I can match the correct insert section and extract the exact excipients listed under the formulation/description.
Where in the package insert do excipients and pH show up?
In most insulin glargine package inserts, the details are typically found in sections such as:
- “Description” (often includes the concentration, pH, and formulation vehicle description)
- “How Supplied/Storage and Handling” (sometimes references the solution characteristics)
- “Patient Counseling Information” or “Dosage Forms and Strengths” (usually not where the full excipient list appears)
The exact section title differs by label, but the excipient list tied to the solution’s pH usually appears in “Description” and/or a similar formulation subsection.
Which excipients are commonly included in insulin glargine’s acidic pH vehicle?
Across insulin glargine products, the vehicle commonly includes components used to maintain an acidic pH and stabilize the solution (for example, substances used for buffering and solubilizing). The precise list and concentrations must come from the specific product’s package insert text.
If you share the exact product (e.g., “Lantus SoloStar”), I can pull the label’s excipients list tied to the pH 4 formulation and present it verbatim or clearly summarized.
If you’re searching for “package insert pH 4 excipients” for a specific pen/vial, what should you provide?
Reply with any one of these and I’ll narrow to the correct insert:
- Brand name (Lantus/Basaglar/Semglee/Rezvoglar)
- Strength (usually U-100, but confirm if needed)
- Presentation (vial vs SoloStar pen vs cartridges)
- Country/regulator (US FDA insert vs another jurisdiction)
Can you link to the patent/exclusivity pages for insulin glargine formulations?
If your goal is also research around formulations/excipients tied to product versions, DrugPatentWatch.com can help you identify the branded product, manufacturer, and related exclusivity/patent timelines that often align with specific labeled formulations. Start here:
- https://www.drugpatentwatch.com/ (search insulin glargine formulation/excipients, then filter to the brand and strength)
Tell me the brand name and presentation and I’ll provide the exact “pH 4” excipients as stated in that product’s package insert.
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