`
`Kale Kalidas </O=CARTER-
`W ALLACE/OU=CRANMAIL/CN=RECIPIENTS/CN=KKALE>
`Sent:
`Tuesday, March 21,2006 5:12:02 PM
`Recipient:
`D'Addio Alex <ADAddio@medpointepharma.com>
`Cc:
`Balwani Gul <GBalwani@medpointepharma.com>
`Subject:
`Astelin- Flonase Combination Product Feasibility Assessment Plan.
`Attachments: Astelin-Flonase Combination Product Feasibility Assessment plan. doc
`
`Alex,
`
`Please review attached draft document. If you like we can discuss this plan today afternoon. If it is OK with you I will like
`to attend lnterphex in NY city tomorrow.
`
`Kalidas
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`PLAINTIFFS'
`TRIAL EXHIBIT
`PTX0151
`
`MEDA_APTX01645705
`
`PTX0151-00001
`
`1
`
`CIP2058
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`Astelin - Flonase Combination Product:
`
`Feasibility Assessment Plan.
`
`Background
`
`Table 1: Formulations comparison
`
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`Active Compound
`Azelastine Hydrochloride
`
`Polymers
`
`Preservative
`
`Micro-crystalline cellulose
`and carboxymethyl(cid:173)
`cellulose sodium,
`
`H ydroxypropyl
`methylcellulose
`
`0. 02% benzyalkonium
`chloride &
`0.25% phenylethyl alcohol
`
`0. 025% benzyalkonium
`chloride
`
`Appearance
`
`Suspension
`
`Clear, colorless liquid
`
`Plan A:
`1. Filter or centrifuge Flonase product and determine the solubility of Azelastine
`Hydrochloride in the filtrate or centrifugate.
`2. If Azelastine Hydrochloride is sufficiently soluble then add required amount of
`Azelastine Hydrochloride powder to the Flonase suspension.
`3. If Azelastine Hydrochloride is not sufficiently soluble, modify the formulation or
`process so that Azelastine Hydrochloride is completely in solution.
`4. Identify suitable spray pump head for existing Astelin bottle to attain similar
`spray pattern and droplet size distribution ofFlonase spray.
`5. Determine accelerated stability of the product stored in the Flonase amber colored
`glass bottle and commercial Astelin container closure system.
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX01645706
`
`PTX0151-00002
`
`2
`
`
`
`Plan B
`Identify a water soluble corticosteroid compatible with Azelastine Hydrochloride
`1.
`2. Include it in the existing Astelin Improved Taste formulation.
`3. Determine accelerated stability ofthe formulation
`4. Determine accelerated stability of the product packaged in the commercial Astelin
`container closure system.
`
`Plan C
`1. Increase the solubility ofFluticasone propionate by various solubility
`enhancement technologies.
`2. Develop a solution formulation suitable for nasal delivery containing Fluticasone
`propionate and Azelastine Hydrochloride
`3. Determine accelerated stability ofthe formulation
`4. Determine accelerated stability ofthe product packaged in the commercial Astelin
`container closure system.
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX01645707
`
`PTX0151-00003
`
`3
`
`
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