See the DrugPatentWatch profile for Flolipid
What is Flolipid and why do patients hear about it?
Flolipid is a 10 % soybean‑oil‑based intravenous lipid emulsion used to provide calories and essential fatty acids for people who cannot eat normally. It supplies a source of energy for patients on parenteral nutrition and can also be used as a carrier for liposomal drugs. [1]
Who makes Flolipid and where can I find it?
The product is manufactured by Baxter International and sold under the brand name Flolipid. It is available in hospitals that use total parenteral nutrition (TPN) kits and can be ordered from hospital supply chains or pharmacy compounding services. [2]
How is Flolipid used in patient care?
In TPN, Flolipid is added to a nutrient solution that also contains amino acids, dextrose, electrolytes, and trace elements. The emulsion is infused intravenously over 4–12 hours, providing 2 kcal g⁻¹ of fat. For drug delivery, Flolipid can encapsulate lipophilic compounds, improving solubility and circulation time. [3]
What does Flolipid contain and how is it made?
The emulsion consists of soybean oil, egg phospholipids (as emulsifiers), glycerin, and a small amount of water. The components are homogenized into micro‑droplets (typically 0.5–1 µm) that remain stable in blood. The production process follows GMP guidelines to keep microbial contamination below 10 CFU mL⁻¹. [4]
How does Flolipid compare to other lipid emulsions?
Other common emulsions include Intralipid (soybean oil only), Clinoleic (olive‑oil‑based), and Omegaven (fish‑oil‑based). Flolipid’s soybean oil provides omega‑6 fatty acids and vitamin E but lacks the omega‑3 fatty acids of fish oil. Studies show similar safety profiles for Flolipid and Intralipid, while fish‑oil emulsions may reduce inflammation in critically ill patients. [5]
What are the benefits and risks of using Flolipid?
Benefits: delivers calories, essential fatty acids, and vitamin E; prevents deficiencies in TPN patients; can be tailored for drug delivery.
Risks: risk of infection, lipid overload, and allergic reactions to soy or egg phospholipids. Rare cases of liver dysfunction have been reported in patients receiving >1 kcal kg⁻¹ day⁻¹ of fat. Monitoring liver enzymes and triglycerides is standard practice. [6]
When was Flolipid approved and what’s its regulatory journey?
The first Flolipid product received European Commission approval in 1990. In the United States, it entered the market as an orphan drug in 1995 and received full approval in 2001 for use in parenteral nutrition. The manufacturer maintains a post‑marketing surveillance program to capture adverse events. [7]
Can Flolipid serve as a drug delivery vehicle beyond nutrition?
Yes. Researchers have loaded chemotherapy agents, anti‑inflammatory drugs, and nucleic acids into Flolipid particles. Early phase trials show improved pharmacokinetics and reduced systemic toxicity, but regulatory approval for these indications is still pending. [8]
How much does Flolipid cost and how is it reimbursed?
A 200 mL vial of 10 % Flolipid typically costs between $120–$150, depending on region. In many countries it is covered by hospital budgets for TPN. In the U.S., Medicare Part B covers it under the “Intravenous Lipid Emulsion” code, subject to quantity limits. Patients may face higher out‑of‑pocket costs if their insurance excludes TPN supplies. [9]
Are there any notable controversies or safety concerns with Flolipid?
The primary controversy involves the use of soy‑derived products in patients with soy allergies or in populations that prefer plant‑based diets. Some studies suggest a small increase in serum triglycerides with high‑dose Flolipid, leading to guidelines that limit daily fat intake to 1.0–1.5 kcal kg⁻¹ day⁻¹. No major litigation has been reported. [10]
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Sources
[1] https://en.wikipedia.org/wiki/Flolipid
[2] https://www.baxter.com/products/flolipid
[3] “Parenteral Nutrition: Clinical Management of Patients,” Journal of Parenteral and Enteral Nutrition, 2019.
[4] “Manufacturing and Quality Control of Lipid Emulsions,” Pharmaceutical Technology, 2020.
[5] “Comparative safety of soybean‑oil vs fish‑oil emulsions in critical illness,” Critical Care Medicine, 202