Pharmacology Mechanism of Action : Microbicide; acid-buffering agent. Carbopol P is a negatively charged, high molecular weight, crosslinked, polyacrylic acid. It is the major nonaqueous component in BufferGel. By maintaining a normally acidic vaginal pH below 5. Carbopol P has demonstrated virucidal and spermicidal activity in vitro.
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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. 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. Carbopol P is an acid-buffering agent that may work by maintaining the natural acidic environment of the healthy vagina.
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. 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.
For example, HIV topical microbicides might:. Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions. In most cases, an investigational drug must be proven effective and must show continued safety in a Phase III clinical trial to be considered for approval by FDA for sale in the United States.
The development of Carbopol P vaginal gel for preventing HIV infection has since been discontinued. 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.
If testing of Carbopol P vaginal gel for preventing HIV infection begins again, additional information on possible side effects will be gathered. More information about Carbopol P-related research studies is available from ClinicalTrials. 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. United States National Library of Medicine. 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. PDF documents can be viewed with the free Adobe Reader.
What is Carbopol P? How do topical microbicides work? How are clinical trials of investigational drugs conducted? In what phase of testing is Carbopol P? What are some studies on Carbopol P? What side effects might Carbopol P cause?
Where can I get more information about clinical trials studying Carbopol P? How can I find more information about participating in a clinical trial?
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.
Carbomer 974P NF
Hiremath and K. Chowdary 1. Department of Pharmaceutics, N. Rifampicin biodegradable microcapsules were prepared by feasible emulsification-ionic gelation method for a novel controlled release product. Sodium alginate and Carbopol P were used as coating polymers in different ratios , , and to obtain elegant microcapsules.
Carbopol® 974P NF Polymer
In situ polyelectrolyte complexes formations based on the physical mixture of chitosan and sodium alginate were found and could be used as an oral controlled release matrix. The aim of this work is the assessment of a possible interaction between the particles of chitosan and Carbopol P NF that could modify their technological performance in captopril tablets. The drug and excipients were evaluated as mixtures of powders and tablets. The evaluated parameters were the powder flow rate, the powder compressibility index, and the compactibility and release behavior of the tablets.