Utilized in pharmaceutical products as rheology modifiers, tablet binders, suspension stabilizers, extended release polymers, mucoadhesive aids, and bioavailability enhancers, Carbopol polymers are well known for their versatility and ease of use as pharmaceutical excipients. Products within the Carbopol polymer family are chemically similar in that they are all high molecular weight, crosslinked polyacrylic acid polymers. However, these gel forming polymers differ by their chemical crosslinking and can be grouped into the following categories. Carbopol homopolymers: acrylic acid crosslinked with allyl sucrose or allyl pentaerythritol Carbopol copolymers: acrylic acid and CC30 alkyl acrylate crosslinked with allyl pentaerythritol Carbopol interpolymers: carbomer homopolymer or copolymer that contains a block copolymer of polyethylene glycol and a long chain alkyl acid ester We have made numerous enhancements to the Carbopol polymer family over time to help address regulatory demands, increase product robustness, and improve product handling, including, when mixing or processing Carbopol, ease of polymer dispersion to cut down on processing time.
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What is an investigational drug? An investigational drug is one that is under study and is not approved by the U. Medical research studies are conducted to evaluate the safety and effectiveness of an investigational drug. These research studies are also called clinical trials. Once an investigational drug has been proven safe and effective in clinical trials, FDA may approve the drug for sale in the United States. What is Carbopol P? Carbopol P brand name: BufferGel is an investigational drug that has been studied to prevent sexual transmission of HIV and other sexually transmitted infections STIs.
It is a type of drug product called a topical microbicide. Topical microbicides are products that are applied to the vagina or rectum such as gels, films, or creams or inserted into the vagina such as vaginal rings to prevent getting STIs, such as HIV infection.
By blocking the alkalinizing action of semen in the vagina, Carbopol P may inactivate HIV and prevent the virus from multiplying. The gel has been studied for vaginal use. How do topical microbicides work? Topical microbicides can also be referred to as topical pre-exposure prophylaxis PrEP products. Topical microbicides to prevent HIV infection are designed to work close to where they are applied and near to where HIV might enter the body through the vagina or rectum.
How are clinical trials of investigational drugs conducted? Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions. The purpose is to evaluate its safety and identify side effects. Phase II trials: The investigational drug is administered to a larger group of people — to determine its effectiveness and to further evaluate its safety.
Phase III trials: The investigational drug is administered to large groups of people 1,—3, to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the investigational drug to be used safely.
In what phase of testing is Carbopol P? Study Design: Participants were randomly assigned to use either Carbopol P microbicide gel, PRO gel, a placebo gel, or no gel at all. Participants who were assigned to a gel group were instructed to apply the gel vaginally 1 hour or less before each episode of vaginal intercourse.
Women used the gels for approximately 20 months. Results: When Carbopol P vaginal gel was compared to placebo gel and to no gel, Carbopol P was found to have no effect on preventing HIV infection or other STIs gonorrhea infection, chlamydia infection, and trichomoniasis.
PRO, the other investigational microbicide tested in the study, had a modest level of effectiveness in preventing HIV infection, but the results were not statistically significant.
What side effects might Carbopol P cause? Where can I get more information about clinical trials studying Carbopol P? More information about Carbopol P-related research studies is available from ClinicalTrials. How can I find more information about participating in a clinical trial? Participating in a clinical trial can provide benefits.
For example, a volunteer participant can benefit from new research treatments before they are widely available. Participants also receive regular and careful medical attention from a research team that includes doctors and other health professionals.
However, clinical trials may also involve risks of varying degrees, such as unpleasant, serious, or even life-threatening side effects from the treatment being studied. ChemIDplus Advanced. Last accessed on April 16, J Pharm. Safety and Effectiveness of BufferGel and 0. Sex Transm Infect. Topical Microbicides. Stone A, Jiang S. Microbicides: stopping HIV at the gate. Low pH immobilizes and kills human leukocytes and prevents transmission of cell-associated HIV in a mouse model.
BMC Infect Dis. Nutan, Gupta SK. Microbicides: a new hope for HIV prevention. Indian J Med Res. In: ClinicalTrials. Registered on December 11, Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial. Obstet Gynecol. Registered on August 1, Contraceptive efficacy, safety, fit, and acceptability of a single-size diaphragm developed with end-user input.
Registered on December 19, Shattock RJ, Rosenberg Z. Cold Spring Harb Perspect Med. PLoS Med. Trial finds microbicide promising as HIV prevention method for women.
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