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1. (WO2019003062) FORME GALÉNIQUE INVIOLABLE COMPRENANT UN AGENT PHARMACEUTIQUEMENT ACTIF
Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

CLAIMS

The tamper-proof dosage form comprising oncological active agent or other active ingredient which is susceptible to topical or nasal contact and leads to adverse clinical symptom.

The tamper-proof dosage form according to claim 1 further comprising polyalkylene oxide.

The tamper-proof dosage form according to claim 2, wherein polyalkylene oxide may be selected from polymethylene oxide, polyethylene oxide, polypropylene oxide; polyethylene, polypropylene and like.

The tamper-proof dosage form according to claim 2 and 3, wherein molecular weight of polyalkylene oxide is at least 50000g/mol.

The tamper-proof dosage form according to claim 1 wherein breaking strength ranges from 250N to 600N.

Tamper-proof dosage form according to claim 1, wherein oncological active agent or other active ingredient is selected from the group consisting of Dasatinib, Sunitinib, Afatinib, Imatinib, Ponatinib, Ibrutinib, Axitinib, Lenvatinib, Bosutinib, Alectinib, Decitabine, Nilotinib, Lapatinib, Trametinib, Erlotinib, Osimertinib, Dabrafenib, Vandetanib, Crizotinib, Ceritinib, Everolimus, Etoposide, Paclitaxel, Irinotecan, Docetaxel, Vincristine, Carboplatin, Cisplatin, Oxaliplatin, Bevacizumab, Cetuximab, Trastuzumab, Denosumab, Rituximab, Zoledronate, Abiraterone, Anastrozole, Bicalutamide, Exemestane, Goserelin, Medroxyprogesterone, Octreotide, Tamoxifen, Bendamustine, Carmustine, Chlorambucil, Lomustine, Melphalan, Procarbazine, Streptozocin, Fludarabine, Raltitrexed, Actinomycin D / Dactinomycin, Doxorubicin, Mitoxantrone, Eribulin, Topotecan, Vinblastine, Vinorelbine, Sorafenib, Trastuzumab emtansine, Temsirolimus, Vemurafenib, Ibandronic acid, Pamidronate, Bexarotene, Buserelin, Cyproterone, Degarelix, Folinic acid, Fulvestrant, Lanreotide, Lenalidomide, Letrozole, Leuprorelin, Megestrol, Mesna and Thalidomide.

Tamper-proof dosage form according to claim 1 and 6, wherein oncological active agent is preferably Dasatinib, Sunitinib, Afatinib, Imatinib, Ponatinib, Ibrutinib, Axitinib, Lenvatinib, Bosutinib, Alectinib, Decitabine, Nilotinib, Lapatinib,

Trametinib, Erlotinib, Osimertinib, Dabrafenib, Vandetanib, Crizotinib, everolimus and Ceritinib; more preferably Dasatinib, Imatinib or salt thereof. The process of manufacturing the tamper-proof dosage form comprising the steps of

i) Admixing the oncological active agent or other active ingredient which is susceptible to topical or nasal contact with polyalkylene oxide

ii) Optionally mixing the same with one or more pharmaceutically acceptable excipient

iii) Compress it into the tablets

iv) Compressed tablets were exposed to curing at temperature of 70°C for 2 hours