Partner Therapeutics
MA - Lexington
Biotechnology2 H-1B visas (FY2023)Focus: Biologics
Partner Therapeutics is a life sciences company focused on Biologics.
Open Jobs
0
Products & Portfolio (2)
2 discontinued products not shown
ALINIA
nitazoxanide
LOE Approaching
ORAL · TABLET
12.1 Mechanism of Action Nitazoxanide is an antiprotozoal [ )]. 12.3 Pharmacokinetics Absorption Single Dosing : Following oral administration of ALINIA Tablets or Oral Suspension, the parent drug, nitazoxanide, is not detected in plasma. The pharmacokinetic parameners of the metabolites, tizoxanide and tizoxanide glucuronide are shown in Tables 2 and 3 below. Table 2. Mean (+/- SD) plasma pharmacokinetic parameters of tizoxanide and tizoxanide glucuronide following administration of a single dose of one 500 mg ALINIA Tablet with food to subjects ≥12 years of age Tizoxanide Tizoxanide Glucuronide Age C max (µg/mL) *T max (hr) AUC t (µg•hr/mL) C max (µg/mL) *T max (hr) AUC t (µg•hr/mL) 12 - 17 years 9.1 (6.1) 4.0 (1-4) 39.5 (24.2) 7.3 (1.9) 4.0 (2-8) 46.5 (18.2) >18 years 10.6 (2.0) 3.0 (2-4) 41.9 (6.0) 10.5 (1.4) 4.5 (4-6) 63.0 (12.3) *T max is given as a Mean (Range) Table 3. Mean (+/-SD) plasma pharmacokinetic of tizoxanide and tizoxanide glucuronide parameter values following administration of single dose of ALINIA for Oral Suspension with food to subjects ≥1year of age Tizoxanide Tizoxanide Glucuronide Age Dose C max (µg/mL) *T max (hr) AUC t (µg•hr/mL) C max (µg/mL) *T max (hr) AUC inf (µg•hr/mL) 1-3 years 100 mg 3.11 (2.0) 3.5 (2-4) 11.7 (4.46) 3.64 (1.16) 4.0 (3-4) 19.0 (5.03) 4-11 years 200 mg 3.00 (0.99) 2.0 (1-4) 13.5 (3.3) 2.84 (0.97) 4.0 (2-4) 16.9 (5.00) >18 years 500 mg 5.49 (2.06) 2.5 (1-5) 30.2 (12.3) 3.21 (1.05) 4.0 (2.5-6) 22.8 (6.49) *T max is given as a Mean (Range) Multiple dosing: Following oral administration of a single ALINIA Tablet every 12 hours for 7 consecutive days, there was no significant accumulation of nitazoxanide metabolites tizoxanide or tizoxanide glucuronide detected in plasma. Bioavailability: ALINIA for Oral Suspension is not bioequivalent to ALINIA Tablets. The relative bioavailability of the suspension compared to the tablet was 70%. When ALINIA Tablets are administered with food, the AUC t of tizoxanide and tizoxanide glucuronide in plasma is increased almost two-fold and the C max is increased by almost 50%. When ALINIA for Oral Suspension was administered with food, the AUC t of tizoxanide and tizoxanide glucuronide increased by about 45-50% and the C max increased by ≤10%. ALINIA Tablets and ALINIA for Oral Suspension were administered with food in clinical trials and hence they are recomended to be administered with food [see Dosage and Administration (2.1)] Distribution In plasma, more than 99% of tizoxanide is bound to proteins. Elimination Metabolism Following oral administration in humans, nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide (desacetyl-nitazoxanide). Tizoxanide then undergoes conjugation, primarily by glucuronidation. Excretion Tizoxanide is excreted in the urine, bile and feces, and tizoxanide glucuronide is excreted in urine and bile. Approximately two-thirds of the oral dose of nitazoxanide is excreted in the feces and one-third in the urine. Specific Popula
diarrhea caused by Giardia lambliaCryptosporidium parvum
2005
30
SUCRALFATE
sucralfate oral
Post-LOE
ORAL · SUSPENSION
2024
30
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Interview Prep Quick Facts
Portfolio: 4 approved products
H-1B (2023): 2 approvals
Portfolio Health
LOE Approaching3 (75%)
Post-LOE1 (25%)
4 total products
Visa Sponsorship
Sponsors Work Visas
H-1B Petitions (FY2023)
2
Approved
0
Denied
100%
Rate
Source: USCIS H-1B Employer Data Hub