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1018 Exhibit: Ex 1017 Jessen

Document IPR2021-01132, No. 1018-18 Exhibit - Ex 1017 Jessen (P.T.A.B. Jun. 17, 2021)

Slovenia Slovakia Senegal Swaziland Chad Togo Tajikistan Turkmenistan Turkey Trinidad and Tobago Ukraine Uganda United States of America Uzbekistan Viet Nam Yugoslavia Zimbabwe Apotex Exhibit 1017.002

Moreover, in these patients there exists a strong correlation between the increased fasting plasma glucose levels and the rate of hepatic glu cose production (reviewed in R.A. De Fronzo: Diabetes 37 (1988), 667 - 687; A. Consoli: Apotex Exhibit 1017.003

Several regulatory processes may influence these hypothalamic centres: Metabolic signals such as postprandial increases in plasma glucose and insulin; meal-induced gastric disten sion is another possible inhibitory factor.

For use within the present invention (2R,3R,4R)-3,4-dihydroxy-2-hydroxymethyl-pyrrolidine,D- tartrate may be formulated with a pharmaceutically acceptable carrier or excipient to provide a medicament for parenteral, oral, nasal, rectal, pulmonal, buccal, subdermal or intradermal or transdermal administration according to conventional methods.

Examples of solid carriers are lactose, terra alba, sucrose, cyclodextrin, talc, gelatin, agar, pec tin, acacia, magnesium stearate, stearic acid or lower alkyl ethers of cellulose.

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1012 Exhibit: Ex 1011 Wells

Document IPR2021-01132, No. 1012-12 Exhibit - Ex 1011 Wells (P.T.A.B. Jun. 17, 2021)

Thus, it is imperative that the best use of the limited bulk is made, to support the continuing efforts of the synthetic chemists and the biologists, pursuing activity and toxicity screens.

Since any deviation front the horizontal (at saturation) is indicative of impurities, as higher drug loading either promotes or suppresses solubility, the USP uses this method to estimate the purity of meeamyia- mine hydrochloride.

The extent of solubility improvement then largely depends on any specific common ion interaction (section 2.7), particularly with the inorganics, and the size and polarity of the sulphonate or carboxylate counterion.

Group C comprises the fatty acids whose application is generally restricted to exploiting an oily form in topical preparations, soft gelatin capsules or i.m.

Nonetheless it is usually better to formulate with a salt since it will control the pH of the diffusion layer — the saturated, highly concentrated solution immediately adjacent to the dissolving surface.

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