The present invention relates to a package having the pack insert attached to the label on primary pack.
Patient compliance and product safety are the matters of prime concern in the field of pharmaceutical packaging. Pack inserts are one of such means which may be helpful in improving the patient compliance, by providing prescribing information about the drug formulations to the consumers. In view of the above, it has now become a regulatory requirement to put the pack insert along with final drug formulations to be marketed.
Pack inserts are necessarily required to be dispensed along with primary pack for certain product in different countries to fulfill safety, patient compliance and regulatory requirements. In the art, a single primary pack comprising drug formulation is necessarily packed in secondary pack, so that pack insert can be kept inside secondary pack just to comply with the regulatory requirements. But there are too many examples of primary packs which are not required to be packed individually in a secondary pack. These primary packs require a secondary pack, only to incorporate pack inserts. This conventional way of using secondary pack increases the packaging cost, packaging time, and complexity of packaging processes. Wherever allowed by regulators, another practice which is generally followed for these type of primary packs involves packaging of more than one primary packs in a secondary pack and incorporating only one pack insert for all primary packs packed in the secondary packs. However, in such cases the pack insert gets separated from the primary packs during dispensing, thereby depriving the user, of the valuable usage instructions and warnings that are necessary for safe and effective use of the contents of primary packs.
In order to avoid the use of secondary pack merely to incorporate pack insert along with individual primary pack and to avoid deprivation of pack insert from the primary pack at the time of dispensing of drug formulations it would be appropriate to develop an easier way so that pack insert can be incorporated along with individual primary pack without using secondary pack.
Aiming these objectives, certain techniques have been developed in the art such as the concept of pack outsert and use of booklet label. However certain disadvantages were also associated with these package designs. Procedure of incorporating pack outsert or booklet to the packed drug formulation needs special machines and involve tedious processes at the production floors. This lead to additional operation steps and at least 3 times increase in cost. Further if pack insert required some revision, the complete set has to be removed. One such booklet label is disclosed in US Patent No. 4,441,739.
In a further development, labeling system has been developed to provide larger space on the label so that the required information for patient can be printed on the label itself. US Patent Application No. 20070031619 discloses a container having a wrap label. The wrap label has two sections. First section adheres to a surface of the container and a second section that is connected to first section but does not adhere directly to container surface. The container adherent section is adapted to affix to a surface of a container. The wrap section is adapted to wrap around said container. Both section of the label may have printing thereon and the wrap section may have printing on both sides. The wrap label may be unfurled to reveal the printing thereon.
In spite of developments made in the past, there still remains a need to develop an alternative package that incorporates the prescribing information directly on the primary pack, which is more consumers friendly and involves relatively simple, cost-effective and less time consuming process of production.
Hence in one general aspect there is provided a package having the pack insert attached to the label on primary pack.
In another general aspect there is provided a package comprising
a) a primary pack containing drug formulation,
b) a label divided into large and small section through perforation wherein the large section of the label is attached on the primary pack while small section remains free, and
c) a pack insert attached to the small section of the label.
In another general aspect there is provided a process for the preparation of the package comprising the steps of:
a) preparing a label
b) perforating the label to divide it into large and small sections,
c) pasting the large section of the label to the primary pack, and
d) attaching the pack insert to free smaller section of the label.
The package of the present invention provides a consumer friendly, simple, cost-effective and less time consuming means to incorporate pack insert along with each primary pack comprising drug formulations. The package comprises the pack insert at one end of the label pasted on the surface of primary pack comprising drug formulation. The process of incorporating the pack insert on the label pasted on primary pack is simple, cost effective and less time consuming that reduces the extra cost, and time consumed in unnecessary use of secondary pack to contain primary pack. Further it avoids the chances of deprivation of any of the users of the valuable usage instructions and warnings that are necessary for safe and effective use of the drugs.
Representative example of the package of the present invention is disclosed in Figures 1 and 2. The package comprises:
a) a primary pack (1),
b) a label divided into a large (2) and small section (2') through a perforation (2") at one end of it, wherein the large section of the label is attached on the primary pack while small section remains free, and
c) a pack insert (3) attached to the small section of the label.
The end user or consumer may detach the pack insert from the primary pack by tearing off the free section (2') through the perforations (2""). A schematic representation of the step by step process of detaching the pack insert is provided in Figure 3.
The term "pack insert" as used herein may include a document, approved by the regulatory body and furnished by the manufacturer of a drug, for use when dispensing the drug. The document indicates the legal pharmacologic description of
a drug, subject to detailed regulatory specifications, including approved chemical and proprietary names, description and classification, clinical pharmacology, approved indications and usage, contraindications, warnings, precautions, adverse reactions, drug abuse and dependence information, over dosage effects, dosage and administration, formulations, and appropriate references. Such documents are negotiated between the drug's manufacturer(s) and the regulatory body of specific country.
The term "primary pack" for drug formulations as used herein includes a primary package for drug formulations which include but are not limited to bottle, jar, vial, ampoule, syringe, auto injector, and the like. The primary pack may be made up of any material selected from the group consisting of glass, polyethylene polymers High Density Poly Ethylene, Low Density Poly Ethylene, or mixture thereof), Poly vinyl chloride, Poly ethylene tetra phthalate, (single layer or multilayer), paper or laminated paper, any organic or inorganic, metallic or non metallic materials, and the like.
The term "label" as used herein may include any written, printed or graphical material containing drug information disseminated by or on behalf of manufacturer of that drug for use by health care professional.
The pack insert or label may be made up of any material selected form the group consisting of paper, waxed paper, laminated paper, plastic, organic or inorganic polymeric or co polymeric material, and the like.
The term "drug formulations" as used herein includes any pharmaceutical dosage form selected from the group consisting of solid dosage forms e.g. tablets, capsules, lozenges, troches, and the like; semisolid dosage forms e.g. creams, ointments, suppositories, pastes, and the like; and liquid dosage form e.g. injections and other parenteral compositions, syrups, tinctures, solutions, mouth washes, gargles, throat paints, and the like. These drug formulations may primarily be packed in primary packs.
The label and the pack insert of may be attached to the primary pack to form the package of the present invention, using one or more of conventional techniques known in the packaging industry. Automatic and semi-automatic machines are highly suitable for the manufacturing of the packages of the present invention.
In one embodiment the package may be prepared by a process comprising the steps of:
a) preparing a label
b) perforating the label to divide it into large and small sections,
c) pasting the large section of the label to the primary pack comprising drug formulation, and
d) attaching the pack insert to free smaller section of the label.
While there have been shown and described what are the preferred embodiments of the invention, one skilled in the art will appreciate that various modifications in the packaging kit and process of manufacture thereof may be made without departing from the scope of the invention as it is defined by the appended claims.

We Claim:
1. A package having the pack insert attached to the label on primary pack.
2. The package as claimed in claim 1 wherein the label is divided into large and small section through perforation.
3. The package as claimed in claim 2 wherein the large section of the label is attached on the primary pack while small section remains free.
4. The package as claimed in claim 3 wherein the pack insert is attached to the small section of the label.
5. The package as claimed in claim 1 wherein the pack insert or label is made up of material selected form the group consisting of paper, waxed paper, laminated paper, plastic, and organic or inorganic polymeric or co polymeric material.
6. The package as claimed in claim 1 wherein the primary pack is selected form the group consisting of bottle, jar, vial, ampoule, syringe, and auto injector.
7. A process for the preparation of the package comprising the steps of:

a) preparing a label,
b) perforating the label to divide it into large and small sections,
c) pasting the large section of the label to the primary pack, and
d) attaching the pack insert to free smaller section of the label.
8. A package having the pack insert attached to the label on primary pack as
described and illustrated in the figures herein.