Stages and timeline
Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to appreciate that a tablet contains a variety of other substances apart from the drug itself, and studies have to be carried out to ensure that the drug is compatible with these other substances.
Preformulation involves the characterization of a drug's physical, chemical, and mechanical properties in order to choose what other ingredients (known as excipients) should be used in the preparation. In dealing with protein pre-formulation, the important aspect is to understand the solution behavior of a given protein under a variety of stress conditions such as freeze/thaw, temperature, shear stress among others to identify mechanisms of degradation and therefore its mitigation.
Drug Stability Related Websites
Acceptable duration at room temperature for medications
Controlled Room Temperature - USP 797 - Questions and
Creation of a Temperature Stability Database
Drug Stabilty
Drug stability chart nr D0106 Ed01 - B. Braun Medical B.V.
Drug Information Resource Guide
Guidance for Industry #5 - Drug Stability Guidelines Room-temperature Storage of Medications Labeled
Drug stability chart nr D0106 Ed01 - B. Braun Medical B.V.
Room-temperature storage of medications labeled for
Room-temperature storage of medications labeled for
Room-temperature storage of medications labeled for refrigeration
Stability testing - World Health Organization
Stability of Refrigerator and Frozen Drugs
What is the General definition for drug stability and the factors
Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to appreciate that a tablet contains a variety of other substances apart from the drug itself, and studies have to be carried out to ensure that the drug is compatible with these other substances.
Preformulation involves the characterization of a drug's physical, chemical, and mechanical properties in order to choose what other ingredients (known as excipients) should be used in the preparation. In dealing with protein pre-formulation, the important aspect is to understand the solution behavior of a given protein under a variety of stress conditions such as freeze/thaw, temperature, shear stress among others to identify mechanisms of degradation and therefore its mitigation.
- Stages and timeline
- 2 Formulation Types
- 3 Enteral Formulations
- 4 Parenteral Formulations
- 5 Topical Formulations
- 6 See also
- 7 References
Drug Stability Related Websites
Acceptable duration at room temperature for medications
Controlled Room Temperature - USP 797 - Questions and
Creation of a Temperature Stability Database
Drug Stabilty
Drug stability chart nr D0106 Ed01 - B. Braun Medical B.V.
Drug Information Resource Guide
Guidance for Industry #5 - Drug Stability Guidelines Room-temperature Storage of Medications Labeled
Drug stability chart nr D0106 Ed01 - B. Braun Medical B.V.
Room-temperature storage of medications labeled for
Room-temperature storage of medications labeled for
Room-temperature storage of medications labeled for refrigeration
Stability testing - World Health Organization
Stability of Refrigerator and Frozen Drugs
What is the General definition for drug stability and the factors