MEET THE MOST ADVANCED DELIVERY SYSTEM
Dipole Technology in the HypoSpray® (HSP) Solution represents a distinctive approach towards transdermal drug delivery
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Vendor Qualification?The HypoSpray(R) StatSpray system has been qualified by several regulatory agencies as well as pharmacies and health care providers. Extensive clinical safety testing has been conducted on the HypoSpray system, including the FDA's rigorous 21-day Cumulative Irritation Test involving 32 subjects and more than 1,300 exposures. The results indicate that the delivery system is non-toxic and non-irritating. Regulatory agencies such as the FDA, as well as European counterparts like the MHRA and EMA, have reviewed all ingredients and have approved them for trial on seven separate occasions. HypoSpray has registered the product as a Type IV Drug Master File defining a coprocessed Excipient and has filed a Request for Revision with the United States Pharmacopoeia (USP) to add a monograpgh for the system. Quality manufacturing is a hallmark of HypoSpray with all Contract Manufacturing Organizations meeting strict standards of current Good Manufacturing Practice (cGMP). HypoSpray is working with USP to verify quality at our CMO sites by means of the USP Veriified Program, and once successfully audited and reviewed, HypoSpray StatSpray will carry the USP Verified Excipient logo.
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Stability Studies on HSP Solution?YES. Given that the HypoSpray DS formula is anhydrous, it falls under the guidelines outlined in USP <795> Pharmaceutical Compounding - Nonsterile Preparations. According to these standards, the Beyond-Use Date (BUD) for such formulations is set at six months from the date of preparation.
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Microbiology of HSP Solution?According to USP 61 standards, ethanol concentrations exceeding 20% are recognized as potent neutralizing agents. Additionally, Propylene Glycol or Carbonate concentrations surpassing 10% are known to inhibit microbial growth and possess anti-viral properties. The HSP Solution contains ethanol levels exceeding 20%.
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What formulations have been made?Hypospray solution has been used to formulate: Testosterone Progesterone 17 Beta Estradiol Estriol Hormone Combinations Ibuprofen Acetaminophen Lidocaine Tetracaine Prilocaine Diclofenac Sodium Morphine Sulfate Hydromorphone Lorazapam Diazepam Vitamins B12, C, D, E Melatonin Human Insulin Epinephrine Hydroxyzine Cetirizine Semaglutide Tirzepetide Numerous other compounds
Book Call
Ready to revolutionize your compounding pharmacy practice with HSP Solution? Contact our team today to request a sample, schedule a product demonstration, or inquire about pricing and ordering options.
WHY CHOOSE HSP SOLUTION WITH DIPOLE TECHNOLOGY?
Enhanced Formulation Precision Dosing
Versatile Compatibility
Efficient Dispensing
Regulatory Compliance
Increased Patient Safety
THE METHOD
The technology leverages the inherent dipole moments in molecules, employing them to enhance the permeability of drugs through the stratum corneum of the skin, creating permeable pathways and thereby facilitating the transdermal migration of pharmaceutical agents
THE RESULTS
Dipole Technology not only provides an avenue for efficient and targeted drug delivery but also expands the spectrum of drugs that can be administered transdermally, enveloping molecules that have traditionally been challenging to deliver through the skin due to their size or hydrophobicity.
UNLOCK THE POTENTIAL OF COMPOUNDING PHARMACY WITH HSP SOLUTION
Experience the transformative power of Dipole Technology and elevate your compounding pharmacy practice to new heights.
ENHANCED FORMULATION
Dipole Technology, a cutting-edge approach that enhances the solubility, stability, and bioavailability of active pharmaceutical ingredients (APIs). This innovative formulation technique ensures optimal drug delivery and efficacy, allowing compounding pharmacists to create customized medications with confidence
PRECISION DOSING
With HSP Solution, compounding pharmacists can achieve precise dosing accuracy, critical for tailoring medications to individual patient needs. Whether preparing specialized formulations for pain management, hormone replacement therapy, dermatology, or pediatrics, our solution offers unparalleled consistency and reliability.
Book a Call
Ready to revolutionize your compounding pharmacy practice with HSP Solution? Contact our team today to request a sample, schedule a product demonstration, or inquire about pricing and ordering options.