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Research has shown that drug delivery is key to optimizing drug therapy.  Milana Pharm’s hydrogel based technology is an innovative platform designed to optimize drug therapy.  Our platform, TRI-726, focuses on three logics/features of in-situ gelation, sustained-release and bioresorption and adhesion.  The three logics, when combined provide ease of use, better tolerability and therapy compliance. 

In-situ gelation: Milana Pharm’s proprietary in-situ gel system (TRI-726) is a viscous liquid and undergoes solution to gel (sol-to-gel) transition using physiological condition such as body temperature as the trigger.  This property allows the Company’s in-situ gel platform to (a) be easily and directly placed on or at the site of action and (b) transform to a gel following application.
By the process of “reverse thermal gelation”, the viscosity of TRI-726 increases 2 – 4x of its viscosity at room temperature (Fig 1). 

Sustained-erosion:  The platform has the ability to erode over a period of several hours to several days.  This feature not only allows for extended residence of the matrix but also for slow release of the incorporated drug over this period.
In the example below, the erosion rate of the TRI-726 matrix is measured as an estimate of the duration of matrix residence time.  The matrix erodes over 15 days under controlled condition, which represents a 5-fold increase over the tri block copolymer alone (Fig 2).

Bioresorption and adhesion:  TRI-726 uses ingredients that are biocompatible with no known adverse reactions.  The ingredients are hydrophilic as well, making the formulation slowly dissolve in body fluids (bioresorb) and body water (intra and extracellular).  This logic provides the advantage of not requiring subsequent removal at the end of a treatment period.  In addition, the platform exhibits excellent ability to bioadhere at the site of application.
TRI-726 showed excellent bioadhesion potential measured in terms of contact time (the time for which a steel disc of certain weight impregnated with the formulation adhered to a glass plate coated with mucin that was placed over a water bath maintained at 37° C).  The contact time was approximately 2x that measured with the tri block copolymer alone (Fig 3).

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Figure 1: Viscosity profile of TRI-726

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Figure 2: Erosion rate of the TRI-726 matrix

      
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Figure 3: Bioadhesion potential of TRI-726 matrix


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TRI-726 consists of a combination of a tri block copolymer and a natural polysaccharide. The system is designed to take advantage of body temperature to undergo sol-to-gel transition and can be presented, to name a few, as a liquid (viscous or dilute), a semi-solid (gel/paste), a spray, or a foam to suite the need/purpose.  In addition, a number of different drugs can be incorporated to treat various conditions.  TRI-726 meets the biocompatibility testing requirements of ISO/USP and a PCT patent application covering the formulation has been published.