Solaris Biotech

CA - Berkeley

Biotechnology

Focus: Specialized bioprocessing equipment for biotech, pharma, food + more. Benchtop / Pilot / Industrial Bioreactors, Fermenters, TFF.

Solaris Biotech is a life sciences company focused on Specialized bioprocessing equipment for biotech, pharma, food + more. Benchtop / Pilot / Industrial Bioreactors, Fermenters, TFF..

DermatologyWomen's HealthInfectious DiseasesCardiovascular

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Products & Portfolio (7)

CLINDAMYCIN PHOSPHATE

clindamycin phosphate

Post-LOE

TOPICAL · GEL

CLINICAL PHARMACOLOGY Pharmacokinetics: In an open-label, parallel group study of 24 patients with acne vulgaris, once-daily topical administration of approximately 3 to 12 grams/day of clindamycin phosphate for 5 days resulted in peak plasma clindamycin concentrations that were less than 5.5 ng/mL. Following multiple applications of clindamycin phosphate less than 0.04% of the total dose was excreted in the urine. Microbiology: Although clindamycin phosphate is inactive in vitro , rapid in vitro hydrolysis converts this compound to clindamycin, which has antibacterial activity. Clindamycin inhibits bacteria protein synthesis at the ribosomal level by binding to the 50S ribosomal subunit and affecting the process of peptide chain initiation. In vitro studies indicated that clindamycin inhibited all tested Propionibacterium acnes cultures at a minimum inhibitory concentration (MIC) of 0.4 mcg/mL. Cross-resistance has been demonstrated between clindamycin and erythromycin.

2021

CLINDAMYCIN PHOSPHATE AND TRETINOIN

clindamycin phosphate and tretinoin

Post-LOE

TOPICAL · GEL

Clindamycin: [See Microbiology ().] Tretinoin: Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedone formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

TRANSDERMAL · GEL, METERED

Estrogen Receptor Agonists

CLINICAL PHARMACOLOGY Normal Subjects Following a single, intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole) to 12 normal subjects, a mean maximum serum metronidazole concentration of 237 ng/mL was reported (range: 152 to 368 ng/mL). This is approximately 2% of the mean maximum serum metronidazole concentration reported in the same subjects administered a single, oral 500 mg dose of metronidazole (mean C max = 12,785 ng/mL, range: 10,013 to 17,400 ng/mL). These peak concentrations were obtained in 6 to 12 hours after dosing with metronidazole vaginal gel and 1 to 3 hours after dosing with oral metronidazole. The extent of exposure [area under the curve (AUC)] of metronidazole, when administered as a single intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole), was approximately 4% of the AUC of a single oral 500 mg dose of metronidazole (4977 ng-hr/mL and approximately 125,000 ng-hr/mL, respectively). Dose-adjusted comparisons of AUCs demonstrated that, on a mg to mg comparison basis, the absorption of metronidazole, when administered vaginally, was approximately half that of an equivalent oral dosage. Patients with Bacterial Vaginosis Following single and multiple 5 gram doses of metronidazole vaginal gel to 4 patients with bacterial vaginosis, a mean maximum serum metronidazole concentration of 214 ng/mL on day 1 and 294 ng/mL (range: 228 to 349 ng/mL) on day five were reported. Steady state metronidazole serum concentrations following oral dosages of 400 to 500 mg BID have been reported to range from 6,000 to 20,000 ng/mL. Microbiology The intracellular targets of action of metronidazole on anaerobes are largely unknown. The 5-nitro group of metronidazole is reduced by metabolically active anaerobes, and studies have demonstrated that the reduced form of the drug interacts with bacterial DNA. However, it is not clear whether interaction with DNA alone is an important component in the bactericidal action of metronidazole on anaerobic organisms. Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis (see ). Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis , Mobiluncus spp., and Mycoplasma hominis , has not been defined. Nonetheless, metronidazole is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis: Bacteroides spp. Gardnerella vaginalis Mobiluncus spp. Peptostreptococcus spp .

the treatment of bacterial vaginosis (formerly referred toGardnerella vaginitisnonspecific vaginitis+2 more

INTRA-ANAL · OINTMENT

(NO), which activates guanylate cyclase, resulting in an increase of guanosine 3',5'-monophosphate (cyclic GMP) in smooth muscle and other tissues. This leads to dephosphorylation of myosin light chains, which regulates the contractile state in smooth muscle and results in vasodilatation.

moderate to severe pain associated with chronic anal fissure

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Interview Prep Quick Facts

Portfolio: 7 approved products

Top TAs: Dermatology, Cardiovascular, Infectious Diseases

Portfolio Health

Post-LOE7 (100%)

7 total products

Therapeutic Area Focus

2 marketed

1 marketed

1 marketed

1 marketed

Marketed

Pipeline

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Stable

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