Structure of Ropinirole. The first step in this proposed program will be to collaborate closely with NuPathe to identify [**]. Also, analytical methods will be transferred to Brookwood at this time. A thorough and complete sharing of technical information on the Ropinirole will help Brookwood design formulation and process approaches. Second, Brookwood will [**]. Brookwood Pharmaceuticals is uniquely positioned to develop drug-delivery products for its pharmaceutical partners. Brookwood’s drug-delivery technologies have broad technical capabilities. Therefore, we are developing drug-delivery products indicated for many therapeutic areas. In particular, Brookwood specializes in long-acting parenteral delivery, like injectable implants and microparticles. Brookwood’s implant platform is a proven delivery system for small molecules, peptides, and some proteins. Depending on the indication and drug properties, active pharmaceutical ingredients can be delivered at efficacious levels for days, weeks, or months following a single administration. Our formulation approach will be to formulate Ropinirole with biocompatible, resorbable polymer(s) from the lactide/glycolide class of polymers (PLG polymers). This class of polymers has a long safety record starting with its use in resorbable sutures in the early 1970s, followed by use in many medical devices and drug-delivery products. including Decapeptyl LP, Lupron Depot®, Profact® Depot, Supercur® MP, Sandostatin LAR®, Trelstar Depot, Zoladex®, Eligard®, Resiperidol® ConstaTM, and Vivitrol. [**] [A total of one page has been redacted and filed separately with the Securities and Exchange Commission.] The PLG polymers are extremely useful in developing controlled-release implant and microparticle formulations. This class of polymers contains hydrolytically labile ▇▇▇▇▇ ▇▇▇▇▇ along the polymer backbone. Upon exposure to aqueous environments, such as in the case of biological fluids, these polymers degrade by random hydrolysis of these aliphatic-ester linkages. This random chain scission process continues over time and resulting in a lowering of the polymer molecular weight. At some point in time, the molecular weight drops to a sufficient extent causing the polymer formulation to lose its mechanical integrity and begin breaking apart. Hydrolysis of the polymer continues until, ultimately, only the individual monomeric constituents are left behind: namely, glycolic acid and/or lactic acid (see Figure 2). Because these final breakdown products of the polymers are naturally-occurring, endogenous entities, these polymers are considered biodegradable and biocompatible. The actual degradation time is dependent on the polymer composition of glycolide and lactide, end-group chemistries, molecular weight, extent of crystallinity, morphology of the polymer crystallinity, physical geometry and the physicochemical environment. PLG polymers offer several important advantages: 1) These polymers are biocompatible — they break down by hydrolysis to form glycolic acid and lactic acid which in turn break down to carbon dioxide and water. 2) [**] 3) These polymers have been used in many products and are very well accepted by the FDA for use in new products. [**] [**] [**] In order to assess feasibility, we propose that [**]. Brookwood has developed an implant processing technology that will be useful to meet the target criteria for the desired Ropinirole formulation. This technology will support [**]. Ropinirole implants will be made by [**] [**] [A total of one page has been redacted and filed separately with the Securities and Exchange Commission.] This plan of work comprises Brookwood’s development program with the objective being to identify [**]. The tasks listed below describe the specific activities that Brookwood will be performing in the execution of the development program. Some of these tasks will be performed in parallel. [**] [A total of four pages, including the remainder of this page, have been redacted and filed separately with the Securities and Exchange Commission.] [**]. A summary of the types of developmental activities that could be carried out by Brookwood are listed below: [**]
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Structure of Ropinirole. The first step in this proposed program will be to collaborate closely with NuPathe to identify [**]. Also, analytical methods will be transferred to Brookwood at this time. A thorough and complete sharing of technical information on the Ropinirole will help Brookwood design formulation and process approaches. Second, Brookwood will [**]. Brookwood Pharmaceuticals is uniquely positioned to develop drug-delivery products for its pharmaceutical partners. Brookwood’s drug-delivery technologies have broad technical capabilities. Therefore, we are developing drug-delivery products indicated for many therapeutic areas. In particular, Brookwood specializes in long-acting parenteral delivery, like injectable implants and microparticles. Brookwood’s implant platform is a proven delivery system for small molecules, peptides, and some proteins. Depending on the indication and drug properties, active pharmaceutical ingredients can be delivered at efficacious levels for days, weeks, or months following a single administration. Our formulation approach will be to formulate Ropinirole with biocompatible, resorbable polymer(s) from the lactide/glycolide class of polymers (PLG polymers). This class of polymers has a long safety record starting with its use in resorbable sutures in the early 1970s, followed by use in many medical devices and drug-delivery products. including Decapeptyl LP, Lupron Depot®, Profact® Depot, Supercur® MP, Sandostatin LAR®, Trelstar Depot, Zoladex®, Eligard®, Resiperidol® ConstaTM, and Vivitrol. [**] [A total of one page has been redacted and filed separately with the Securities and Exchange Commission.] The PLG polymers are extremely useful in developing controlled-release implant and microparticle formulations. This class of polymers contains hydrolytically labile ▇▇▇▇▇ ▇▇▇▇▇ along the polymer backbone. Upon exposure to aqueous environments, such as in the case of biological fluids, these polymers degrade by random hydrolysis of these aliphatic-ester linkages. This random chain scission process continues over time and resulting in a lowering of the polymer molecular weight. At some point in time, the molecular weight drops to a sufficient extent causing the polymer formulation to lose its mechanical integrity and begin breaking apart. Hydrolysis of the polymer continues until, ultimately, only the individual monomeric constituents are left behind: namely, glycolic acid and/or lactic acid (see Figure 2). Because these final breakdown products of the polymers are naturally-occurring, endogenous entities, these polymers are considered biodegradable and biocompatible. The actual degradation time is dependent on the polymer composition of glycolide and lactide, end-group chemistries, molecular weight, extent of crystallinity, morphology of the polymer crystallinity, physical geometry and the physicochemical environment. PLG polymers offer several important advantages:
1) These polymers are biocompatible — they break down by hydrolysis to form glycolic acid and lactic acid which in turn break down to carbon dioxide and water.
2) [**]
3) These polymers have been used in many products and are very well accepted by the FDA for use in new products. [**] [**] [**] In order to assess feasibility, we propose that [**]. Brookwood has developed an implant processing technology that will be useful to meet the target criteria for the desired Ropinirole formulation. This technology will support [**]. Ropinirole implants will be made by [**] [**] [A total of one page has been redacted and filed separately with the Securities and Exchange Commission.] This plan of work comprises Brookwood’s development program with the objective being to identify [**]. The tasks listed below describe the specific activities that Brookwood will be performing in the execution of the development program. Some of these tasks will be performed in parallel. [**] [A total of four pages, including the remainder of this page, have been redacted and filed separately with the Securities and Exchange Commission.] [**]. A summary of the types of developmental activities that could be carried out by Brookwood are listed below: [**]
Appears in 1 contract